RECRUITING

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-09-04

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05964829

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Douglas A Wajda, PhD

CONTACT

3308837149

d.a.wajda@csuohio.edu

Rebecca Webster, PhD

CONTACT

925-788-6649

rebecca@cionic.com

Principal Investigator

Douglas A Wajda, PhD

PRINCIPAL_INVESTIGATOR

Cleveland State University

Study Locations (Sites)

Cleveland State University

Cleveland, Ohio, 44115

United States

Collaborators and Investigators

Sponsor: Cionic, Inc.

Douglas A Wajda, PhD, PRINCIPAL_INVESTIGATOR, Cleveland State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-04

Study Completion Date2026-01

Study Record Updates

Study Start Date2023-09-04

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

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