Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

NCT05964829 | Recruiting FDA Device

• 1 other identifier: CIONIC-06-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Change in Gait Speed

  The Timed 25-Foot Walk Test (T25FWT) to record duration of time to walk a distance of 25 feet, measured in seconds. The score is the average of two successive trials.

  Day 0, Week 6, Week 12

• Change in Perceived Walking Ability

  Multiple Sclerosis Walking Scale-12 (MSWS-12) to measure perceived impact of MS on walking ability, measured by score. Scores on the MSWS-12 range from 12-60 and transformed to a scale with a range from 0 to 100, with high scores indicative of a greater impact of MS on walking.

  Day 0, Week 6, Week 12

• Change in MS Disability

  A 9-item survey, Patient-Determined Disease Steps (PDDS), will measure of disability status in individuals with MS. The PDDS ranges from 0 to 8, with higher values indicative of higher levels of disability.

  Day 0, Week 6, Week 12

• Amount of Daily Walking/Activity Level

  Collected by the usage log of the device, measured in steps per day

  During allocation to receive the functional electrical stimulation arm

• Duration of Daily Walking/Activity Level

  Collected by the usage log of the device, measured in duration of activity.

  During allocation to receive the functional electrical stimulation arm

Other Outcomes (13)

• Change in Health-Related Quality of Life

  Day 0, Week 6, Week 12

• Change in Impact of MS

  Day 0, Week 6, Week 12

• Change in Perceived Fatigue

  Day 0, Week 6, Week 12

Study Arms (2)

Control

EXPERIMENTAL

Participants will follow the walking program.

Behavioral: Walking Program

Functional electrical stimulation

EXPERIMENTAL

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

Device: Cionic Neural Sleeve NS-100; Behavioral: Walking Program

Interventions

Cionic Neural Sleeve NS-100 DEVICE

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.

Functional electrical stimulation

Walking Program BEHAVIORAL

15 minutes of walking for 5 days per week for 6 weeks

Control; Functional electrical stimulation

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cionic, Inc.: lead

Study Sites (1)

Cleveland State University

Cleveland, Ohio, 44115, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas A Wajda, PhD

  Cleveland State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas A Wajda, PhD

CONTACT

3308837149; d.a.wajda@csuohio.edu

Rebecca Webster, PhD

CONTACT

925-788-6649; rebecca@cionic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 28, 2023
• Study Start: September 4, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)