Coverage Policy Manual
Policy #: 1997080
Category: Rehabilitation
Initiated: August 2017
Last Review: February 2024
  Neuromuscular Stimulation, Functional

Description:
This policy addresses functional neuromuscular electrical stimulation and treatment of disuse atrophy as described.
 
Functional electrical stimulation (FES) involves the use of an orthotic device or exercise equipment with microprocessor-controlled electrical muscular stimulation. These devices are being developed to restore function and improve health in patients with damaged or destroyed nerve pathways (e.g., spinal cord injury [SCI], stroke, multiple sclerosis, cerebral palsy).
 
Functional electrical stimulation (FES) is an approach to rehabilitation that applies low-level electrical current to stimulate functional movements in muscles affected by nerve damage. It focuses on the restoration of useful movements, like standing, stepping, pedaling for exercise, reaching, or grasping.
 
FES devices consist of an orthotic and a microprocessor-based electronic stimulator with one or more channels for delivery of individual pulses through surface or implanted electrodes connected to the neuromuscular system. Microprocessor programs activate the channels sequentially or in unison to stimulate peripheral nerves and trigger muscle contractions to produce functionally useful movements that allow patients to sit, stand, walk, and grasp. Functional neuromuscular stimulators are closed loop systems, which provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters which are required for complex activities such as walking. These are contrasted with open loop systems, which are used for simple tasks such as muscle strengthening alone. Healthy individuals with intact neural control benefit the most from this technology.
 
Applications include upper extremity grasping function after spinal cord injury and stroke, lifting the front of the foot during ambulation in individuals with foot drop, ambulation, and exercise for patients with spinal cord injury.
 
One application of functional electrical stimulation (FES) is to restore upper extremity functions such as grasp-release, forearm pronation, and elbow extension in patients with stroke, or C5 and C6 tetraplegia (quadraplegia).
 
NeuroControl Corp. developed the Freehand System, an implantable upper extremity neuroprosthesis intended to improve a patient's ability to grasp, hold, and release objects for use in patients with tetraplegia due to C5 or C6 spinal cord injury. NeuroControl is no longer in business, but FES centers in the United States and United Kingdom provide maintenance for implanted devices.
 
The NESS H200 (previously known as the Handmaster NMS I system) is an upper-extremity device that uses a forearm splint and surface electrodes. The device, controlled by a user-activated button, is intended to provide hand function (fine finger grasping, larger palmar grasping) for patients with C5 tetraplegia or stroke.
 
Other hand stimulators that have been cleared for marketing in the United States are:
 
    • ReGrasp by Rehabtronics
    • MyndMove by MyndTec. This device is currently being studied in a clinical trial for rehabilitation.
 
 
Other FES devices have been developed to provide FES for patients with foot drop. Foot drop is weakness of the foot and ankle that causes reduced dorsiflexion and difficulty with ambulation. It can have various causes such as cerebral palsy, stroke, or multiple sclerosis (MS). FES of the peroneal nerve has been suggested for these patients as an aid in raising the toes during the swing phase of ambulation.
 
With these devices, a pressure sensor detects heel-off and initial contact during walking. A signal is then sent to the stimulation cuff, initiating or pausing the stimulation of the peroneal nerve, which activates the foot dorsiflexors. Examples of such devices used for treatment of foot drop are:
 
    • WalkAide by Innovative Neurotronics (formerly NeuroMotion)
    • L300 Go by Bioness
    • MyGait by Otto Bock
    • OFDS (Odstock Foot Drop Stimulator) and ODFS Pace XL by Odstock.
 
An implantable peroneal nerve stimulator system (ActiGait®) is being developed by Otto Bock in Europe.
 
Another application of FES is to provide spinal cord-injured patients with the ability to stand and walk. Using percutaneous stimulation, the device delivers trains of electrical pulses to trigger action potentials at selected nerves at the quadriceps (for knee extension), the common peroneal nerve (for hip flexion), and the paraspinals and gluteals (for trunk stability). Patients use a walker or elbow-support crutches for further support. The electrical impulses are controlled by a computer microchip attached to the patient’s belt that synchronizes and distributes the signals. In addition, there is a finger-controlled switch that permits patient activation of the stepping.
 
Other devices include a reciprocating gait orthosis with electrical stimulation. The orthosis used is a cumbersome hip-knee-ankle-foot device linked together with a cable at the hip joint. The use of this device may be limited by the difficulties in putting the device on and taking it off.
  
Regulatory Status
 
A variety of FES devices have been cleared by the U.S. Food and Drug Administration (FDA) and are available for home use. Below is a list of examples of devices designed to improve hand and foot function as well as cycle ergometers for home exercise. The date of the FDA clearance is for the first 510(k) clearance identified for a marketed device. Many devices have additional FDA clearances as the technology evolved, each in turn listing the most recent device as the predicate.
 
Functional Electrical Stimulation Devices Cleared by the FDA
 
    • Freehand®, which is no longer manufactured, is a Hand stimulator that received clearance in 1997
    • NESS H200® (previously Handmaster), manufactured by Bioness, is a Hand stimulator (K022776) that received clearance in 2001. Product code GZC
    • MyndMove System, manufactured by MyndTec, is a Hand stimulator (K170564) that received clearance in 2017. Product code GZI/IPF
    • ReGrasp, manufactured by Rehabtronics, is a Hand stimulator (K153163) that received clearance in 2016. Product code GZI/IPF
    • WalkAide® System, manufactured by Innovative Neurotronics (formerly NeuroMotion), is a Foot drop stimulator (K052329) that received clearance in 2005. Product code GZI
    • ODFS® (Odstock Dropped Foot Stimulator), manufactured by Odstock Medical, is a Foot drop stimulator (K050991) that received clearance in 2005. Product code GZI
    • ODFS® Pace XL, manufactured by Odstock Medical, is a Foot drop stimulator (K171396) that received clearance in 2018. Product code GZI/IPF
    • L300 Go, manufactured by Bioness, is a Foot drop stimulator (K190285) that received clearance in 2019. Product code GZI/IPF
    • L100 Go, manufactured by Bioness, is a Foot drop stimulator (K200262) that received clearance in 2020. Product code GZI/IPF
    • Foot Drop System, manufactured by SHENZHEN XFT Medical, is a Foot drop stimulator (K162718) that received clearance in 2017. Product code GZI
    • Nerve And Muscle Stimulator, manufactured by SHENZHEN XFT Medical, is a Foot drop stimulator (K193276) that received clearance in 2020. Product code GZI
    • MyGait® Stimulation System, manufactured by Otto Bock HealthCare, is a Foot drop stimulator (K141812) that received clearance in 2015. Product code GZI
    • ERGYS (TTI Rehabilitation Gym), manufactured by Therapeutic Alliances, is a Leg cycle ergometer (K841112) that received clearance in 1984. Product code IPF
    • RT300, manufactured by Restorative Therapies, Inc (RTI), is a Cycle ergometer (K050036) that received clearance in 2005. Product code GZI
    • Myocycle Home, manuractured by Myolyn, is a Cycle ergometer (K170132) that received clearance in 2017. Product code GZI
    • StimMaster Orion, manufactured by Electrologic, is no longer in business.
 
To date, the Parastep® Ambulation System is the only noninvasive functional walking neuromuscular stimulation device to receive premarket approval from the FDA. The Parastep device is approved to “enable appropriately selected skeletally mature spinal cord injured patients (level C6-T12) to stand and attain limited ambulation and/or take steps, with assistance if required, following a prescribed period of physical therapy training in conjunction with rehabilitation management of spinal cord injury” (CMS, 2002). FDA product code: MKD

Policy/
Coverage:
EFFECTIVE May 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Neuromuscular electrical stimulation (NMES) meets primary coverage criteria for effectiveness and is covered for the treatment of disuse atrophy when there is an intact nerve supply to the muscle including brain, spinal cord, and peripheral nerves. This includes the use of NMES for the treatment of disuse atrophy in the following situations:
 
    • secondary to prolonged splinting or casting of the affected extremity,
    • contracture due to scarring of soft tissue as in burn lesions,
    • following hip replacement surgery until orthotic training begins.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of neuromuscular electrical stimulation (NMES) for any other condition or indication not listed above as covered, including but not limited to the use of NMES for the following indications, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
 
    • Use of NMES in individuals with cardiac demand pacemakers
    • Use of NMES in individuals with cancer
    • To treat pain associated with various musculoskeletal conditions, including, but not limited to patellofemoral syndrome, spinal stenosis, lumbago, muscle strains, and muscle sprains
    • To prevent muscle atrophy
    • As a technique to increase circulation
    • When primarily used for comfort or convenience
 
For members with contracts without primary coverage criteria, the use of neuromuscular electrical stimulation (NMES) for ALL other condition or indication not listed above as covered, including but not limited to the use of NMES for the following indications, is considered investigational.
 
    • Use of NMES in individuals with cardiac demand pacemakers
    • Use of NMES in individuals with cancer
    • To treat pain associated with various musculoskeletal conditions, including, but not limited to patellofemoral syndrome, spinal stenosis, lumbago, muscle strains, and muscle sprains
    • To prevent muscle atrophy
    • As a technique to increase circulation
    • When primarily used for comfort or convenience
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Functional neuromuscular electrical stimulation used to enhance functional activity of neurologically impaired patients does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, functional neuromuscular electrical stimulation used to enhance functional activity of neurologically impaired patients is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Functional electrical stimulation exercise equipment for home use does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, functional electrical stimulation exercise equipment for home use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
FES devices including but not limited to the following are considered home exercise equipment:
 
      • ERGYS leg cycle ergogemeter,
      • REGYS leg cycle
      • RT200 Elliptical
      • RT300 RES cycle ergogemeter (also referred to as FES bicycle),
      • StimMaster Galaxy (FES exercise bike)  
      • RT600 Step and Stand Rehabilitation Therapy System for stationary exercise
 
Myoelectric controlled upper-limb orthoses (e.g., MyoPro) do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness (see policy 2010011).
 
For members with contracts without primary coverage criteria, myoelectric controlled upper-limb orthoses (e.g., MyoPro) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage (see policy 2010011).
 
EFFECTIVE JUNE 2019 to APRIL 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Neuromuscular electrical stimulation (NMES) meets primary coverage criteria for effectiveness and is covered for treatment of disuse atrophy where nerve supply to the muscle is intact, including but not limited to atrophy secondary to prolonged splinting or casting of the affected extremity, contracture due to scarring of soft tissue as in burn lesions, and hip replacement surgery (until orthotic training begins).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Neuromuscular electrical stimulation (NMES) for conditions other than disuse atrophy does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  For members with contracts without primary coverage criteria, neuromuscular electrical stimulation (NMES) is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
NMES devices are contraindicated for:
 
    • Patients with cardiac demand pacemakers;  
    • Patients with cancer.    
 
Use for these conditions does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, use for these conditions would be considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Functional neuromuscular electrical stimulation used to enhance functional activity of neurologically impaired patients does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, functional neuromuscular electrical stimulation used to enhance functional activity of neurologically impaired patients is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Functional electrical stimulation exercise equipment for home use does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, functional electrical stimulation exercise equipment for home use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
FES devices including but not limited to the following are considered home exercise equipment:
 
    • ERGYS leg cycle ergogemeter,
    • REGYS leg cycle
    • RT200 Elliptical
    • RT300 RES cycle ergogemeter (also referred to as FES bicycle),
    • StimMaster Galaxy (FES exercise bike)  
    • RT600 Step and Stand Rehabilitation Therapy System for stationary exercise
 
Myoelectric controlled upper-limb orthoses (eg MyoPro) do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness (see policy 2010011).
 
For members with contracts without primary coverage criteria, myoelectric controlled upper-limb orthoses (eg MyoPro) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage (see policy 2010011).
 
EFFECTIVE PRIOR TO JUNE 2019
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Neuromuscular electrical stimulation (NMES) meets primary coverage criteria for effectiveness and is covered for treatment of disuse atrophy where nerve supply to the muscle is intact, including but not limited to atrophy secondary to prolonged splinting or casting of the affected extremity, contracture due to scarring of soft tissue as in burn lesions, and hip replacement surgery (until orthotic training begins).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Neuromuscular electrical stimulation (NMES) for conditions other than disuse atrophy does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  For members with contracts without primary coverage criteria, neuromuscular electrical stimulation (NMES) is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Functional neuromuscular electrical stimulation used to enhance functional activity of neurologically impaired patients does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, functional neuromuscular electrical stimulation used to enhance functional activity of neurologically impaired patients is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
NMES devices are contraindicated for:
        • Patients with cardiac demand pacemakers;
        • Patients with cancer.   
 
Use for these conditions does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, use for these conditions would be considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to April 2012
 
 
Functional Neuromuscular Stimulation is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, Functional Neuromuscular Stimulation is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Neuromuscular electrical stimulation (NEMS) meets primary coverage criteria for effectiveness and is covered for treatment of disuse atrophy secondary to prolonged splinting or casting of the affected extremity.  Neuromuscular electrical stimulation (NEMS) for other conditions is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, Neuromuscular electrical stimulation (NEMS) is considered not medically necessary. Medically unnecessary services are an exclusion in the member certificate of coverage.
 
EMS devices are contraindicated for:
    • Patients with cardiac demand pacemakers;
    • Patients with cancer.  
Use for these conditions is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, EMS devices are contraindicated for:
    • Patients with cardiac demand pacemakers;
    • Patients with cancer.  
Use for these conditions would be considered not medically necessary.  Medically unnecessary services are an exclusion in the member certificate of coverage.

Rationale:
The clinical impact of the Parastep device rests on identification of clinically important outcomes. The primary outcome of the Parastep device and the main purpose of its design is to provide a degree of ambulation that improves the patient’s ability to complete the activities of daily living, seek employment, or positively benefit the patient’s quality of life. Physiologic outcomes (i.e., conditioning, oxygen uptake, etc.) have also been reported, but these are intermediate short term outcomes, and it is not known whether similar or improved results could be attained with other training methods. In addition, the results are reported for mean peak values, which may or may not be a consistent result over time. The effect of the Parastep on physical self-concept and depression are secondary outcomes and similar to the physiologic outcomes; interpretation is limited due to lack of comparison with other forms of training.
 
The largest study was conducted by Chaplin et. al. who reported on the ambulation outcomes using the Parastep I in 91 patients.  Of these 91 patients, 84 (92%) were able to take steps and 31 (34%) were able to eventually ambulate without assistance from another person. Duration of use was not reported. Other studies on the Parastep device include a series of 5 studies from the same group of investigators, which focused on different outcomes in the same group of 13–15 patients.  In a 1997 study, Guest and colleagues reported on the ambulation performance of 13 men and 3 women with thoracic motor complete spinal injury.   All patients underwent 32 training sessions prior to measuring ambulation. The group mean peak distance walked was 334 meters, but there was wide variability, as evidenced by a standard deviation of 402 meters. The mean peak duration of walking was 56 minutes, again with wide variability, evidenced by a standard deviation of 46 minutes. It should be noted that peak measures reflect the best outcome over the period evaluated; peak measures may be an inconsistent one-time occurrence for the individual patient. The participants also underwent anthropomorphic measurements of various anatomic locations. Increases in thigh and calf girth, thigh cross-sectional area, and calculated lean tissue were all statistically significant. The authors emphasize that the device is not intended to be an alternative to a wheelchair, and thus other factors such as improved physical and mental well being should be considered when deciding whether or not to use the system. The same limitations were noted in a review article by Graupe and Kohn, who state that the goal for ambulation is for the patients to get out of the wheelchair at will, stretch, and take a few steps every day.
 
Jacobs and colleagues reported on physiologic responses related to use of the Parastep device.  There was a 25% increase in time to fatigue and a 15% increase in peak values of oxygen uptake, consistent with an exercise training effect. There were no significant effects on arm strength. Needham-Shropshire and colleagues reported no relationship between use of the Parastep device and bone mineral density, although the time interval between measurements (12 weeks), and the precision of the testing device, may have limited the ability to detect a difference.  Nash and colleagues reported that use of the Parastep device was associated with an increase in arterial inflow volume to the common femoral artery, perhaps related to the overall conditioning response to the Parastep.  Also, Guest and colleagues reported significant improvements in physical self-concept and decreases in depression scores.   Finally, it should be noted that evaluations of the Parastep device were performed immediately following initial training or during limited study period durations.  There are no data regarding whether patients remain compliant and committed with long-term use.
 
Summary
As stated by various authors the Parastep system it is not designed to be an alternative to a wheelchair and offers, at best, limited, short-term ambulation. Final health outcomes, such as ability to perform activities of daily living or quality of life have not been reported.
 
2002 Update
A search of the literature was performed on the MEDLINE database for the period of 2000 to October 2002. No published data were identified that would alter the above conclusion; therefore the policy statement is unchanged. Brissot and colleagues reported independent ambulation was achieved in 13 of 15 patients, with 2 patients withdrawing from the study.  In the home setting, 5 of the 13 patients continued using the device for physical fitness, but none used it for ambulation. Sykes and colleagues found low use of a reciprocating gait orthosis device (RGOs) with or without stimulation over an 18-month period.   In addition, the more recent Davis study of a surgically implanted neuroprosthesis for standing and transfers after spinal cord injury showed mixed usability/preference scale results for ambulation with device assistance versus conventional transfers in 12 patients followed up for a 12-month period post-discharge.  Therefore, the advantage of using device assistance could not be evaluated.
 
2005 Update
Updated searches of the literature were performed in the MEDLINE database for the period of 2000 to April 2005. No published data were identified that would alter the above conclusion; therefore, the policy statement is unchanged. Brissot and colleagues reported independent ambulation was achieved in 13 of 15 patients, with 2 patients withdrawing from the study.  In the home setting, 5 of the 13 patients continued using the device for physical fitness, but none used it for ambulation. Sykes and colleagues found low use of a reciprocating gait orthosis device (RGOs) with or without stimulation over an 18-month period.  In addition, the more recent Davis study of a surgically implanted neuroprosthesis for standing and transfers after spinal cord injury showed mixed usability/preference scale results for ambulation with device assistance versus conventional transfers in 12 patients followed up for a 12-month period post-discharge.  Therefore, the advantage of using device assistance could not be evaluated.
 
2006 Update
An updated search of the literature was performed on the MEDLINE database for the period of April 2005 through May 2006. No published data were identified that would alter the above conclusions; therefore, the policy statement is unchanged. Daly and colleagues compared gait component execution in 32 post-stroke patients randomized to gait training with or without FNS.  The authors found gait training with FNS with intramuscular electrodes significantly improved gait component execution (as measured by the Tinetti gait measure, a 12-point scale to assess gait component coordination) and knee flexion coordination over gait training without FNS. However, improvements in balance, overall limb coordination, and the 6-minute walking test were not statistically significant. In addition, final health outcomes, such as the ability to perform activities of daily living or quality of life were not evaluated in this study.
 
2007 Update
A search of the MEDLINE database was conducted for the period of June 2006 through September 2007. The limited published literature suggests that this procedure is at an early experimental stage in patients with spinal cord injury. For example, Forrest and colleagues reported oxygen consumption for a single subject implanted with the Case Western Reserve/Veterans Administration (CWRU/VA) standing neuroprosthesis.  The 12-month post-implantation assessment is part of an ongoing standardized experimental protocol funded by the New York State Department of Health Spinal Cord Injury Research Board, the U.S. Food and Drug Administration Office of Orphan Product Development, a Department of Veterans Affairs Rehabilitation and Development Merit Review, and the National Institute of Health.  The subject was able to stand for up to 2 hours and ambulate 8 to 15 feet in 1 minute using parallel bars. Oxygen consumption while standing was 4.7 mL/kg/min, about twice the expected energy use of a nondisabled person. At a reported ambulation speed of 2.4 to 4.5 meters per minute, the neuroprosthesis was considered to be practical only for standing, transfers, and ambulation for very short distances. Another study, which was funded by the National Center for Medical Rehabilitation Research of the National Institute for Child Health and Development, examined strategies for improving balance during functional tasks (such as reaching and manipulating objects at a counter) in 2 spinal cord injury patients using neuromuscular stimulation devices (1 with the CWRU/VA and 1 with Octostim surface electrodes).  It was reported that 1 of the 2 subjects attained the goal of placing at least 90% of his/her body weight on the lower extremities during standing, potentially allowing safe release of a hand for functional use. A number of publicly listed clinical trials are assessing the effectiveness of functional neuromuscular stimulation following stroke.  The literature indicates that functional neuromuscular neurostimulation is investigational; the policy statement remains unchanged.
 
2012 Update
A literature review using the MEDLINE database was conducted through January 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2012 Update
This policy is updated with a literature search using the MEDLINE database through January 2013. The update focuses on the new literature on the use of neuromuscular stimulation for the treatment of children with cerebral palsy.
 
Cerebral Palsy
Cauraugh et al. conducted a 2010 meta-analysis of 17 studies on NMES and gait in children with cerebral palsy (Cauraugh, 2010). Fourteen of the studies used a pretest-post-test, within-subjects design. A total of 238 participants had NMES. Included were studies on acute NMES, functional NMES and therapeutic NMES (continuous subthreshold stimulation). Five of the studies examined functional NMES, and 1 of these studies examined percutaneous NMES. There were 3 outcome measures for impairment; range of motion, torque/moment, and strength/force. There were 6 different outcome measures for activity limitations; gross motor functions, gait parameters, hopping on one foot, 6-minute walk, Leg Ability Index, and Gillette gait index. Moderate effect sizes were found for impairment (0.616) and activity limitations (0.635). The systematic review is limited by a lack of blinding in the included studies and the heterogeneity of outcome measures. The review did not describe if any of the included studies used a commercially available device.
 
A 2012 report examined the acceptability and effectiveness of a commercially available foot drop stimulator in 21 children who had mild gait impairments and unilateral foot drop (Prosser, 2012). Three children did not experience an improvement in walking and did not complete the study. Gait analysis in the remaining 18 showed improved dorsiflexion when compared to baseline. There was no significant change in other gait parameters, including walking speed. The average daily use was 5.6 hours (range, 1.5 to 9.4) over the 3 months of the study, although the participants had been instructed to use the device for at least 6 hours per day. Eighteen children (86%) chose to keep using the device after the 3-month trial period. Data from this period were collected but not reported.
 
In 2013, Meilahn assessed the tolerability and efficacy of a commercially available neuroprosthesis in 10 children (age, 7-12 years) with hemiparetic cerebral palsy who typically wore an ankle foot orthosis for correction of foot drop (Meilahn, 2013).  All of the children tolerated the fitting and wore the device for the first 6 weeks. The mean wear time was 8.4 hours per day in the first 3 weeks and 5.8 hours per day in the next 3 weeks. Seven children (70%) wore the device for the 3-month study period, with average use of 2.3 hours daily (range, 1.0 to 6.3 hours/day). Six children (60%) continued to use the neuroprosthesis after study completion. Gait analysis was performed, but quantitative results were not included in the report. Although it was reported that half of the subjects improved gait velocity, mean velocity was relatively unchanged with the neuroprosthesis.
 
In summary, two recent within-subject studies have evaluated tolerability and efficacy of a commercially available neuroprosthesis in children with cerebral palsy. Both of the studies, which should be considered preliminary, show no improvement in walking speed with the device. In addition, daily use decreased over the course of one trial. Study in a larger number of subjects over a longer duration is needed to permit conclusions concerning the effect of the technology on health outcomes.
 
2014 Update
A literature search was conducted using the MEDLINE database through February 2014. There was no new literature identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
FASTEST (NCT01138995) is an industry-sponsored single-blinded multicenter trial that randomized 197 patients to 30 weeks of a footdrop stimulator (NESS L300) or a conventional ankle-foot orthosis (AFO) (Kluding, 2013). The AFO group received transcutaneous electrical nerve stimulation at each physical therapy visit during the first 2 weeks to provide a sensory control for stimulation of the peroneal nerve in the NESS L300 group. Evaluation by physical therapists who were blinded to group assignment found that both groups improved gait speed and other secondary outcome measures over time, with similar improvement in the 2 groups. There were no between-group differences in the number of steps per day at home, which were measured by an activity monitor over a week. User satisfaction was higher with the footdrop stimulator.
 
A multicenter within-subject crossover trial of the WalkAid footdrop stimulator versus conventional AFO was published in 2013 (Everaert, 2013). Patients who had a stroke within the previous12 months and residual footdrop but no prior experience with an orthotic device were randomly assigned to WalkAid followed by AFO (6 weeks each, n=38), AFO followed by WalkAid (n=31), or AFO for 12 weeks (n=24). Walking tests were performed both with and without a device at 0, 3, 6, 9, and 12 weeks. The orthotic effect of the device is considered to be the immediate effect of NMES measured at any of the time points with the stimulator on compared with off. The therapeutic effect is the improvement over time (improvement in neuromuscular function) measured under the same conditions (ie, stimulator on versus on or stimulator off versus off) at different time points. The Physiological Cost Index (PCI), which is an indication of the amount of effort in walking, is assessed by the difference between resting heart rate and heart rate during walking, divided by the average walking speed. Both devices had significant orthotic (on-off difference) and therapeutic (changes over time when off) effects. The AFO had a greater orthotic effect on walking speed (figure 8 and 10-meter), while the WalkAid tended to have a greater therapeutic effect. The orthotic effect on PCI was significantly higher with an AFO than the WalkAid. Users felt equally safe with the 2 devices. Seventy percent preferred to keep the WalkAid after the 12-week study.
 
Ongoing Clinical Trials
A search of online site www.ClinicalTrials.gov in March 2014 identified the following studies with a neuroprosthesis:
 
  • NCT00890916 is a phase I/II study from the Department of Veteran Affairs of the FIRSTHAND System in patients with spinal cord injury. There is an estimated enrollment of 7 patients with anticipated completion in December 2013.
  • NCT00583804 will evaluate the efficacy of an implanted stimulator and sensor on hand and arm function in 50 patients with spinal cord injury. Estimated study completion date is January 2014.
 
Also identified were a number of studies on functional NMES for treatment of patients with acute and chronic stroke conditions. These trials primarily focus on rehabilitation and strengthening.
  
2015 Update
 
A literature search conducted through February 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Randomized Controlled Trials
Functional NMES with a foot-drop stimulator (WalkAide) was compared with an ankle-foot orthosis in an industry-affiliated multicenter randomized controlled trial (NCT01087957) that included 495 Medicare eligible individuals who were at least 6 months post-stroke (Bethoux, 2014).  A total of 399 individuals completed the 6 month study. Primary outcome measures were the 10-Meter Walk Test (10MWT), a composite measure of daily function, and device-related serious adverse event rates. There were 7 secondary outcome measures that assessed function and quality of life. Intention-to-treat analysis found that both groups improved walking performance over the 6 months of the study and the NMES device was non-inferior to the ankle-foot orthosis on the primary outcome measures. Only the WalkAide group showed significant improvements from baseline to 6 months on several secondary outcome measures, but there were no significant between-group differences for any of the outcomes.
 
Secondary analysis of data from this study was reported in 2014 (O’Dell, 2014). Comfortable gait speed was assessed in the 99 individuals from the NESS L300 group at 6, 12, 30, 36, and 42 weeks, with and without use of the footdrop stimulator. A responder was defined as achieving a minimal clinically important difference (MCID) of 0.1 m/sec on the 10-m walk test (10MWT) or advancing by at least 1 Perry Ambulation Category. Non-completers were classified as non-responders. Seventy percent of participants completed the assessments at 42 weeks, and 67% of participants were classified as responders. Out of the 32 participants who were classified as non-responders, 2 were non-responders and 30 were non-completers. The percentage of patients in the conventional AFO group who were classified as responders at 30 weeks was not reported. There were 160 adverse events (AEs), of which 92% were classified as mild. Fifty percent of the AEs were related to reversible skin issues and 27% were falls.
 
Ongoing and Unpublished Clinical Trials
A search of online site www.ClinicalTrials.gov in December 2014 identified the following studies with a neuroprosthesis:
  • NCT00890916 is a phase 1/2 study from the Department of Veteran Affairs of the FIRSTHAND System in patients with spinal cord injury. There is an estimated enrollment of 7 patients with anticipated completion in December 2013. 2014.
  • NCT00583804 will evaluate the efficacy of an implanted stimulator and sensor on hand and arm function in 50 patients with spinal cord injury. Estimated study completion date is January 2014. 2027.
  • NCT01237860 is a manufacturer-sponsored phase 3 study of the NESS L300 Plus System. Enrollment was estimated at 45 patients with completion in January 2011. This study had an enrollment of 45 and is listed as completed. No results have been posted.
 
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2018. No new literature was identified that would prompt a change in the coverage statement.  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Two meta-analyses evaluated FES in treatment of patients with foot drop secondary to stroke.
 
da Cunha et al performed a meta-analysis of 14 parallel-group or crossover studies (n=1115) of FES applied to the paretic peroneal nerve (da Cunha, 2021). Compared with supervised exercises along, FES was not superior in improving gait speed. FES significantly improved balance as assessed with the Berg Balance Scale (ranging from 0-56, with higher scores indicating improvement) and functional mobility as assessed by the Timed Up and Go test; however, heterogeneity was high for these outcomes. The overall quality of evidence was assessed as low.
 
Nascimento et al performed a meta-analysis of 11 parallel-group studies (n=1135) of ankle-foot orthoses (AFO) or FES (Nascimento, 2020). Walking speed was significantly improved compared with no treatment with both AFOs and FES. In comparisons of active treatments, AFO and FES did not significantly differ in outcomes of walking speed or balance as measured by the Berg Balance Scale. However, both analyses included few studies (4 and 2 studies, respectively). The overall quality of evidence was assessed as moderate.
 
A multicenter RCT on FES for dropped foot by Hachisuka et al compared FES with a dropped foot stimulator (WalkAide) with no device treatment in a randomized, open-label trial in 119 patients with post-stroke foot drop who were at least 4 months poststroke (Hachisuka, 2020). At 4 weeks, there were no significant differences between groups in the primary endpoint of change from baseline in 6MWT or the secondary endpoint of change from baseline in 10MWT.
 
Prokopiusova et al performed a randomized trial that compared FES (combined with postural correction) and neuroproprioceptive facilitation and inhibition physiotherapy for 2 months in patients with MS and foot drop (Prokopiusova, 2020). Main study outcomes were assessed immediately after and 2 months after program completion and included 2-minute walk test, timed 25-foot walk test, timed up-and-go (TUG) test, Scale, Activities-Specific Balance Confidence Scale, and Berg Balance Scale. While the group treated with FES experienced significant improvements immediately after program completion in Activities-Specific Balance Confidence Scale and Berg Balance Scale, none of these outcomes significantly differed between groups at either time point. The study was limited by a lack of blinding of patients and clinicians.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Dolbow et al evaluated the efficacy of FES cycling (RT300) along with nutrition counseling for 8 weeks in 10 obese adults with SCI (Dolbow, 2021). The participants were treated with either FES cycling plus nutrition counseling (n=5) or nutrition counseling alone (n=5). The cycling group completed high intensity interval cycling for 30 minutes 3 times weekly. The cycling group improved body fat and lean leg mass to a greater extent than those who received nutrition counseling alone.
 
Farkas et al compared FES leg cycling (ERGYS2) with arm cycling in 13 patients with SCI (Farkas, 2021). Patients exercised 5 times weekly for 16 weeks with greater improvement in exercise energy expenditure and cardiorespiratory fitness in patients exercising with arm cycling than in patients exercising with FES leg cycling. A major limitation in relevance of the studies for the present evidence review is that they do not appear to have been conducted in the home environment. The REGYS and ERGYS cycle ergometers have a bulky integrated seat and require transfer from a wheelchair, which may be a significant limitation to home use. Sustained motivation to exercise for 2 to 3 times per week outside of the investigational setting is uncertain.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January  2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A multi-center, single-blind, parallel-group, RCT comparing FES delivered by the MyndMove device (n=27) to conventional therapy (n=24) in adults with C4 to C7 SCI was conducted (Anderson, 2022) The FES therapy consisted of 36 to 40 one-hour sessions within a 14-week period, while conventional therapy consisted of the same time frame, but participants received upper limb conventional therapy instead. The primary outcome was the change in baseline of spinal cord injury independence measure III - self-care (SCIM-SC) scores. Both groups gained a mean of 2 points in SCIM-SC scores at the end of treatment, which was clinically meaningful, and this impact persisted at the end of the study (24 weeks from the 1st session). However, there was no statistically significant difference between the groups on any outcomes. This trial was limited by the small number of participants(power was not reached) and interruptions of therapy sessions due to the COVID-19 pandemic lockdown in the U.S. and Canada. Additionally, the participants in the FES group were likely more severely impaired than those in the conventional therapy group based on baseline characteristics. Randomization was stratified by site and not on severity of injury.
 
A systematic review of 14 RCTs measuring the impact of FES on mobility in children with cerebral palsy was conducted (Chen, 2023) Included RCTs compared FES with placebo or conventional therapy (N=421). While there was overlap of studies included in Cauraugh et al (2010), Chen et al (2023) also included unique studies. Compared with the control group, children who received FES demonstrated greater improvement in walking speed (7 studies, n=213; SMD, 0.29; 95% CI, 0.02 to0.57; p=.04) and the standing, walking, running, and jumping dimension of the Gross Motor Function Measure (9 studies, n=302;SMD, 1.24; 95% CI, 0.64 to 1.83; p<.0001). Five RCTs (n=198) reported on adverse effects of FES, and no adverse events were reported in any trial. Participants were not blinded in any of the studies and therapists were not blinded in most of the studies. Long-term effects of FES could not be determined based on the short duration of follow-up of included studies. Additionally, parameters and location of the stimulation differed across studies. Despite risk of bias identified across trials, the studies included in this systematic review were deemed to be of moderate quality using the Grading of Recommendations, Assessment, Development and Evaluation method.
 
A systematic review and meta-analysis was conducted of 9 RCTs (N=282) on FES and gait in children with cerebral palsy, including more recent studies than other systematic reviews (Zhu, 2022). Of the children included across studies, 142 were in the FES therapy group and 140 were in the control group, which included comfort treatment, general nursing, or other physical therapy. All studies were included in analysis of walking speed and step length, with no significant heterogeneity among studies. Meta-analysis demonstrated that walking speed was increased after FES compared with the control group (standard mean difference [SMD], 0.82; 95% confidence interval [CI], 0.57 to 1.07; p<.0001). Additionally, FES increased the walking step length compared to the control group (SMD, 1.34; 95% CI, 1.07 to 1.60; p<.0001). Most studies had limitations in blinding methods of participants, and most of them were single-blind studies. Additionally, there is an overall lack of high-quality RCTs contributing to evidence, and authors concluded that more research with larger populations was needed.

CPT/HCPCS:
64580Incision for implantation of neurostimulator electrode array; neuromuscular
E0745Neuromuscular stimulator, electronic shock unit
E0764Functional neuromuscular stimulation, transcutaneous stimulation of sequential muscle groups of ambulation with computer control, used for walking by spinal cord injured, entire system, after completion of training program
E0770Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified
E1399Durable medical equipment, miscellaneous

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Centers for Medicare & Medicaid Services (CMS).(2021) Decision Memo for Neuromuscular Electrical Stimulation (NMES) for Spinal Cord Injury (CAG-00153R). 2002; https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=55. Accessed February 25, 2021.

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