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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 22 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05964829
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cionic, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Douglas A Wajda, PhD
Principal Investigator Affiliation Cleveland State University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
Additional Details

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.

Arms & Interventions

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

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.

Device: - Actigraph accelerometer

Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland State University, Cleveland, Ohio

Status

Recruiting

Address

Cleveland State University

Cleveland, Ohio, 44115

Site Contact

Douglas A Wajda

[email protected]

3308837149

Nearest Location

Site Contact

Douglas A Wajda

[email protected]

3308837149


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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