Actively Recruiting
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Led by Cionic, Inc. · Updated on 2025-09-24
14
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
CONDITIONS
Official Title
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland State University
Cleveland, Ohio, United States, 44115
Actively Recruiting
Research Team
D
Douglas A Wajda, PhD
CONTACT
R
Rebecca Webster, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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