Multiple SclerosisNCT05964829
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
A study testing Cionic Neural Sleeve NS-100 and Walking Program in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Cionic, Inc. at 1 site in United States.
Trial summary
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
- What is being tested?
- Cionic Neural Sleeve NS-100 and Walking Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2023to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland State University
Cleveland, Ohio, 44115
Douglas A Wajda
About this study
Official title: 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).
Read the 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.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
- Being tested
- Cionic Neural Sleeve NS-100, Walking Program
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cionic Neural Sleeve NS-100Device
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 ProgramBehavioural
15 minutes of walking for 5 days per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Participants will follow the walking program. Receives: Behavioral: Walking Program |
| Functional electrical stimulation | Experimental | Participants will follow the walking program and receive stimulation assistance during the walking sessions. Receives: Device: Cionic Neural Sleeve NS-100; Behavioral: Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: During allocation to receive the functional electrical stimulation arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start4 Sep 2023
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cionic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas A Wajda, PhD, Principal investigator, Cleveland State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964829
- Sponsor's protocol ID
- CIONIC-06-001
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05964829
- Acronym / sponsor ID
- CIONIC-06-001
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cionic, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Walking ProgramParticipants will follow the walking program. |
| Functional electrical stimulation | Experimental | Device: Cionic Neural Sleeve NS-100, Behavioral: Walking ProgramParticipants will follow the walking program and receive stimulation assistance during the walking sessions. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cionic Neural Sleeve NS-100The 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. | Device | Functional electrical stimulation |
| Walking Program15 minutes of walking for 5 days per week for 6 weeks | Behavioural | Control, Functional electrical stimulation |
Primary outcome
Change in Gait Speed
Time frame: Day 0, Week 6, Week 12
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.
Change in Perceived Walking Ability
Time frame: Day 0, Week 6, Week 12
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.
Change in MS Disability
Time frame: Day 0, Week 6, Week 12
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.
Amount of Daily Walking/Activity Level
Time frame: During allocation to receive the functional electrical stimulation arm
Collected by the usage log of the device, measured in steps per day
Duration of Daily Walking/Activity Level
Time frame: During allocation to receive the functional electrical stimulation arm
Collected by the usage log of the device, measured in duration of activity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Douglas A Wajda, PhD principal investigator
Cleveland State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cionic Neural Sleeve NS-100 and Walking Program in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Cionic, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Douglas A Wajda, PhD (3308837149, d.a.wajda@csuohio.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Speed (time frame: Day 0, Week 6, Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.