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Recruiting NCT05964829

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

No phase Interventional Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Chronic Progressive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cionic Neural Sleeve NS-100, Walking Program.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive. Basic parameters: 22 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.
  • Behavioral Walking Program
    15 minutes of walking for 5 days per week for 6 weeks

Primary outcome measures

  • Change in Gait Speed [Time frame: Day 0, Week 6, Week 12]
  • Change in Perceived Walking Ability [Time frame: Day 0, Week 6, Week 12]
  • Change in MS Disability [Time frame: Day 0, Week 6, Week 12]
  • Amount of Daily Walking/Activity Level [Time frame: During allocation to receive the functional electrical stimulation arm]
  • Duration of Daily Walking/Activity Level [Time frame: During allocation to receive the functional electrical stimulation arm]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cleveland State University — Cleveland

Identifiers

NCT: NCT05964829 · CIONIC-06-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗