Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

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

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Device: Cionic Neural Sleeve NS-100; Behavioral: Walking Program

Detailed Description

The randomized within-participants crossover 12-week 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 the Cionic Neural Sleeve; 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 Cionic Neural Sleeve on the most impacted leg for 6 weeks, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Cionic Neural Sleeve will be worn for 6 weeks of the study while following the walking program.

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

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Webster, PhD; Phone Number: 925-788-6649; Email: rebecca@cionic.com
• Study Contact Backup: Name: Douglas A Wajda, PhD; Phone Number: 3308837149; Email: d.a.wajda@csuohio.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Recruiting
      • Cleveland State University
      • Contact: Douglas A Wajda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Participants will follow the walking program.	Behavioral: Walking Program; 15 minutes of walking for 5 days per week for 6 weeks
Experimental: Functional electrical stimulation; Participants will follow the walking program and receive stimulation assistance during the walking sessions.	Device: 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.; Behavioral: Walking Program; 15 minutes of walking for 5 days per week for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health-Related Quality of Life	The Euroqol 5 Dimension 5 Level (EQ-5D-5L) questionnaire describes health profiles using different domains, measured by a 5-digit code. Single-digit numbers of the dimensions range from 1 to 5, with 1 indicative of no problem and 5 indicative of extreme problems in that domain.	Day 0, Week 6, Week 12
Change in Impact of MS	Multiple Sclerosis Impact Scale-29 (MSIS-29) questionnaire to measure the physical and psychological impact of MS, measured by score. Scores on the MSIS-29 are transformed into a score out of 100, with higher scores indicative of greater degree of disability.	Day 0, Week 6, Week 12
Change in Perceived Fatigue	Modified Fatigue Impact Scale (MFIS) survey to measure the effects of fatigue in physical, cognitive, and psychosocial functioning. MFIS score ranges from 0 to 84, with high scores indicative of a greater impact of fatigue on activities.	Day 0, Week 6, Week 12
Change in Spasticity	A trained clinician will administer the Modified Ashworth Scale (MAS) to assess for muscle tone and spasticity. Scores of the MAS range from 0 to 4, with high scores representative of increased muscle tone and spasticity.	Day 0, Week 6, Week 12
Change in Lower Limb Strength	Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons.	Day 0, Week 6, Week 12
Change in Ankle Plantarflexor Strength	Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises.	Day 0, Week 6, Week 12
Change in Lower Limb Range of Motion	Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer.	Day 0, Week 6, Week 12
Change in Walking Endurance	Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters.	Day 0, Week 6, Week 12
Change in Balance	Measured using force platform posturography in standing to quantify postural sway. There will be four 30-second trials with eyes open standing as still as possible.	Day 0, Week 6, Week 12
Change in Incidence of Falls	Measured using a self-reported fall diary and a survey, the Hopkins Fall Grading Scale, a 4-point scale to grade the nature and severity of a fall. Higher grades represent increased severity and impact of injurious falls.	From enrollment to end of treatment at 12 weeks
Change in Medication(s) and Dosage	Measured by changes in dose intensities of prescribed medication(s).	Day 0, Week 6, Week 12
Change in Pain	Measured using the questionnaire, the Numeric Pain Rating Scale (NPRS), an 11-point numeric scale ranging from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.	Day 0, Week 6, Week 12
Change in Self-Reported Physical Activity	Subjects will record their weekly physical activity using the Godin-Leisure Time Exercise Questionnaire (GLTEQ), measured by score. Scores less than 14 units are interpreted as insufficiently active/sedentary, while scores between 14 and 23 are interpreted as moderately active, and scores greater than 24 units are interpreted as active.	From enrollment to end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Cionic, Inc.
• Investigators: Principal Investigator: Douglas A Wajda, PhD, Cleveland State University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive
• Other Study ID Numbers: CIONIC-06-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No