Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).

Detailed Description
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The randomized within-participants crossover study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS. Physical measurements, performance-based tests, and questionnaire responses will be recorded. These include physical activity recorded by an Actigraph; in-person tests measuring disability, spasticity and balance; and questionnaires gauging perceived walking ability, quality of life, and physical and psychological impact of MS. All participants will be assigned a hip-worn Actigraph activity monitor, a Cionic Neural Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the 12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the study. Participants will be randomized to one of two groups: A or B. Group A will wear the Actigraph and receive stimulation assisted walking from the Neural Sleeve (intervention), while group B will only wear the Actigraph while walking. After 6 weeks, participants in each group will cross over to the other group.

Official Title
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A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis

Conditions
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Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive

Intervention / Treatment
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* Device: Cionic Neural Sleeve NS-100
* Device: Actigraph accelerometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 75 Ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device Adequate cognitive and communicative function as assessed via Telephone Interview for Cognitive Status (TICS) to identify persons with dementia Able to tolerate the Neural Sleeve device for up to 8 hours per day T25FWT time between 8 and 45 seconds No recent change in medication or recent exacerbation of symptoms over the last 60 days Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5 Exclusion Criteria: Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation Absent sensation in the impacted or more impacted leg Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized History of falls greater than once a week No use of FES devices in the past year Demand-type cardiac pacemaker or defibrillator Malignant tumor in the impacted or more impacted leg Existing thrombosis in the impacted or more impacted leg Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Participants will follow the walking program. | Device: Actigraph accelerometer<br>* Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.<br>|
| Experimental: Functional electrical stimulation<br>Participants will follow the walking program and receive stimulation assistance during the walking sessions. | Device: Cionic Neural Sleeve NS-100<br>* The Cionic Neural Sleeve applies functional electrical stimulation as subjects walk to help contract appropriate muscles at appropriate times. The Cionic Neural Sleeve will be worn for 6 weeks.<br>Device: Actigraph accelerometer<br>* Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gait Speed | The Timed 25-Foot Walk Test (T25FWT) to record duration of time to walk a distance of 25 feet, measured in seconds. The score is the average of two successive trials. | Week 1, Week 6, Week 12 | 
| Change in Perceived Walking Ability | Multiple Sclerosis Walking Scale-12 (MSWS-12) to measure perceived impact of MS on walking ability, measured by score. Scores on the MSWS-12 range from 12-60 and transformed to a scale with a range from 0 to 100, with high scores indicative of a greater impact of MS on walking. | Week 1, Week 6, Week 12 | 
| Change in MS Disability | Expanded Disability Status Scale (EDSS), administered by a trained clinician, to quantify disability in MS and monitor changes in the level of disability over time. The EDSS scale ranges from 0 to 10, with high scores indicative of higher levels of disability. | Day 0, Week 6, Week 12 | 
| Change in Fall Risk | Berg Balance Scale (BBS) to assess balance in 14 tasks, measured by score. Scores of the BBS range from 0 to 56, with 0-20 being wheelchair bound, 21-40 being walking with assistance, and 41-56 classified as independent. | Week 1, Week 6, Week 12 | 
| Amount of Daily Walking/Activity Level | Collected by the usage log of the device(s), measured in steps per day | Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16 | 
| Duration of Daily Walking/Activity Level | Collected by the usage log of the device(s), measured in duration of activity. | Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16 |