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Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks, 5 days, 12 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Physical measurements, performance-based tests, and questionnaire responses will be recorded."
  • "These include physical activity recorded by the Cionic Neural Sleeve; in-person tests measuring disability, spasticity and balance; and questionnaires gauging perceived walking ability, quality of life, and physical and psychological impact of MS."
  • "All participants will be assigned a Cionic Neural Sleeve on the most impacted leg for 6 weeks, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks."
  • "The Cionic Neural Sleeve will be worn for 6 weeks of the study while following the walking program."
  • "Group A will follow the walking program and wear the Neural Sleeve to receive stimulation assisted walking from the Neural Sleeve for 6 weeks."
  • "Group B will follow the walking program for 6 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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

Study sites (1)

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