Actively Recruiting

Phase Not Applicable
Age: 22Years - 75Years
All Genders
NCT05964829

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Led by Cionic, Inc. · Updated on 2025-09-24

14

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Who Can Participate

Age: 22Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Cleveland State University

Cleveland, Ohio, United States, 44115

Actively Recruiting

Loading map...

Research Team

D

Douglas A Wajda, PhD

CONTACT

R

Rebecca Webster, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here