Tests a wearable leg sleeve for mobility in multiple sclerosis
Tests a wearable leg sleeve in adults with multiple sclerosis for mobility.
Plain-language title generated from the registry record
Registry title: Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Key facts
- Where
- Cleveland, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Source: NCT05964829, who can take part
Where in United States
- Cleveland State UniversityCleveland, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cionic, Inc.
- Trial code
- NCT05964829
- Record updated
- 24 September 2025
- Original description
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).Read full original descriptionShow less
A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
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; History of falls greater than once a week; Demand-type cardiac pacemaker or defibrillator; Malignant tumor in the impacted or more impacted leg; Existing thrombosis in the impacted or more impacted leg; 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; No use of FES devices in the past year; Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation.