Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Last updated: March 19, 2025
Sponsor: Cionic, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

Actigraph accelerometer

Cionic Neural Sleeve NS-100

Clinical Study ID

NCT05964829
CIONIC-06-001
  • Ages 22-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Persons with relapsing-remitting or progressive forms of MS between the ages of 22and 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 Interviewfor 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 60days

  • Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5

Exclusion

Exclusion Criteria:

  • Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impairresponse to stimulation

  • Absent sensation in the impacted or more impacted leg

  • Inadequate response to stimulation, defined by inability to achieve musclecontraction or unable to tolerate stimulation

  • Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/kneeankle 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 adverselyaffected by motion from stimulation

Study Design

Total Participants: 14
Treatment Group(s): 2
Primary Treatment: Actigraph accelerometer
Phase:
Study Start date:
September 04, 2023
Estimated Completion Date:
January 31, 2026

Study Description

The randomized within-participants crossover study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS.

Physical measurements, performance-based tests, and questionnaire responses will be recorded. These include physical activity recorded by an Actigraph; 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 hip-worn Actigraph activity monitor, a Cionic Neural Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the 12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the study.

Participants will be randomized to one of two groups: A or B. Group A will wear the Actigraph and receive stimulation assisted walking from the Neural Sleeve (intervention), while group B will only wear the Actigraph while walking. After 6 weeks, participants in each group will cross over to the other group.

Connect with a study center

  • Cleveland State University

    Cleveland, Ohio 44115
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.