Recruiting

Cionic Neural Sleeve

Sponsor:

Cionic, Inc.

Code:

NCT05964829

Conditions

Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Multiple Sclerosis, Chronic Progressive

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Cionic Neural Sleeve NS-100

Walking Program

Study Details

Brief summary:

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

Study ID

NCT05964829

Start date

Sep 4, 2023

Status verified date

Sep, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

14 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Control

Participants will follow the walking program.

experimental: Functional electrical stimulation

Participants will follow the walking program and receive stimulation assistance during the walking sessions.

Interventions

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

Primary outcome measure

  • Change in Gait Speed [ Time Frame: Day 0, Week 6, Week 12 ]
  • Change in Perceived Walking Ability [ Time Frame: Day 0, Week 6, Week 12 ]
  • Change in MS Disability [ Time Frame: Day 0, Week 6, Week 12 ]
  • Amount of Daily Walking/Activity Level [ Time Frame: During allocation to receive the functional electrical stimulation arm ]
  • Duration of Daily Walking/Activity Level [ Time Frame: During allocation to receive the functional electrical stimulation arm ]

Central Contacts and Locations

Central contacts

Douglas A Wajda, PhD

3308837149d.a.wajda@csuohio.edu

Rebecca Webster, PhD

925-788-6649rebecca@cionic.com

Locations

Cleveland State University

Recruiting

Cleveland, Ohio, United States, 44115

More Information

Sponsor

Cionic, Inc.

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cionic, Inc. on 2025-09-24.