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Clinical Trials in the USA / NCT05964829
Recruiting Not applicable

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

NCT05964829 · tracked via the Priya Life Science USA tracker
Sponsor
Cionic, Inc
Phase
Not applicable
Started
2023-09-04
Last updated
2025-09-24

Condition(s) studied

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic Progressive

Investigational drug(s) / intervention(s)

Cionic Neural Sleeve NS-100Walking Program

Cionic Neural Sleeve NS-100: The Cionic Neural Sleeve applies functional electrical stimulation as subjects walk to help contract appropriate muscles at appropriate times. The Cionic Neural Sleeve will be worn for 6 weeks.

Walking Program: 15 minutes of walking for 5 days per week for 6 weeks

Study summary

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

Eligibility

Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Gait Speed — Day 0, Week 6, Week 12
    The Timed 25-Foot Walk Test (T25FWT) to record duration of time to walk a distance of 25 feet, measured in seconds. The score is the average of two successive trials.
  • Change in Perceived Walking Ability — Day 0, Week 6, Week 12
    Multiple Sclerosis Walking Scale-12 (MSWS-12) to measure perceived impact of MS on walking ability, measured by score. Scores on the MSWS-12 range from 12-60 and transformed to a scale with a range from 0 to 100, with high scores indicative of a greater impact of MS on walking.
  • Change in MS Disability — Day 0, Week 6, Week 12
    A 9-item survey, Patient-Determined Disease Steps (PDDS), will measure of disability status in individuals with MS. The PDDS ranges from 0 to 8, with higher values indicative of higher levels of disability.
  • Amount of Daily Walking/Activity Level — During allocation to receive the functional electrical stimulation arm
    Collected by the usage log of the device, measured in steps per day
  • Duration of Daily Walking/Activity Level — During allocation to receive the functional electrical stimulation arm
    Collected by the usage log of the device, measured in duration of activity.

Trial sites (1)

FacilityCityRegionStatus
Cleveland State University Cleveland Ohio Recruiting

More Cionic, Inc. trials in the USA

Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease Recruiting
Tracking Self-Reported Functional Needs and Quality of Life Enrolling by invitation

Other trials for the same condition

"HB-adMSCs for the Treatment of Patients With Multiple Sclerosis" Active, not recruiting
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis Active, not recruiting
A Study of Disease Modifying Therapy Use in Women With Multiple Sclerosis Before, During, and After Pregnancy Active, not recruiting
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis Active, not recruiting
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05964829 on ClinicalTrials.gov ↗ ← All trials in the USA