Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Recruiting now · Not applicable
Conditions studied: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
In brief
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
Key facts
- Study ID
- NCT05964829
- Run by
- Cionic, Inc.
- People needed
- 14
- Starts
- 2023-09-04
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2025-09-24
Who can join
Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- Cleveland State University — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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