Status:
RECRUITING
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Lead Sponsor:
Cionic, Inc.
Conditions:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
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
The randomized within-participants crossover 12-week study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS. Physical measurements, performance-ba...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05964829
Start Date
September 4 2023
End Date
July 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Cleveland State University
Cleveland, Ohio, United States, 44115