Using the Cionic Neural Sleeve to improve mobility in people with multiple sclerosis
A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
This study is testing if wearing the Cionic Neural Sleeve can help people with multiple sclerosis walk better and improve their overall mobility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Cionic, Inc. Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05964829 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 22 to 75 with relapsing-remitting or progressive forms of MS who can ambulate for at least 15 minutes a day.
Not a fit: Patients with lower motor neuron diseases or those unable to tolerate stimulation from the Neural Sleeve may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mobility and quality of life for patients with multiple sclerosis.
How similar studies have performed: While the specific use of the Cionic Neural Sleeve is novel, similar approaches using neuromuscular stimulation have shown promise in improving mobility in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.