Using the Cionic Neural Sleeve to improve mobility in people with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the clinical effectiveness of the Cionic Neural Sleeve in enhancing mobility for individuals diagnosed with multiple sclerosis (MS). The study employs a randomized within-participants crossover design, where participants will wear the Neural Sleeve on their most affected leg while engaging in a prescribed walking regimen. Physical activity will be monitored using an Actigraph device, and various performance-based tests and questionnaires will assess disability, spasticity, balance, and overall quality of life. Participants will alternate between receiving stimulation-assisted walking and standard walking to compare outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland State University
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Douglas A Wajda, PhD — Cleveland State University
• Study coordinator: Douglas A Wajda, PhD
• Email: d.a.wajda@csuohio.edu
• Phone: 3308837149

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.