Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Description

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

Conditions

Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive

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Study Overview

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Study Details

Study overview

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

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

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland State University, Cleveland, Ohio, United States, 44115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

22 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cionic, Inc.,

Douglas A Wajda, PhD, PRINCIPAL_INVESTIGATOR, Cleveland State University

Study Record Dates

2026-01