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Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Cionic, Inc. · NCT05964829

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
14
US sites recruiting
1
Study start
September 4, 2023
Record last updated
September 24, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: Cionic Neural Sleeve NS-100; Walking Program

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Cleveland State University

    Cleveland, OH 44115

    Site contact: Douglas A Wajda

Study contacts (from the official record)

  • Douglas A Wajda, PhD · 3308837149 · d.a.wajda@csuohio.edu
  • Rebecca Webster, PhD · 925-788-6649 · rebecca@cionic.com
All neurology studies in Ohio →
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis (NCT05964829) | Bored Studies