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Device

Cionic Neural Sleeve for Multiple Sclerosis

N/A
Waitlist Available
Led By Douglas A Wajda, PhD
Research Sponsored by Cionic, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, week 1, week 6, week 12, post-intervention at week 16
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the Cionic Neural Sleeve, a device that helps people with MS walk better by sending small electrical signals to their leg muscles. It targets individuals with MS who have trouble walking. The study will measure how well the device improves walking ability and quality of life.

Who is the study for?
This trial is for adults aged 22-75 with relapsing-remitting or progressive multiple sclerosis who can walk at least 15 minutes a day and have moderate mobility impairment. They should not have had medication changes or symptom exacerbation in the last 60 days, and must be able to wear the Neural Sleeve for up to 8 hours daily.
What is being tested?
The study tests the Cionic Neural Sleeve NS-100's effectiveness on mobility in MS patients. Participants will use this device alongside an Actigraph accelerometer to measure movement benefits over time.
What are the potential side effects?
While specific side effects are not listed, potential issues may include discomfort from wearing the sleeve, skin irritation, muscle fatigue from stimulation, or difficulty tolerating electrical stimulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, week 1, week 6, week 12, post-intervention at week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, week 1, week 6, week 12, post-intervention at week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amount of Daily Walking/Activity Level
Change in Fall Risk
Change in Gait Speed
+3 more
Other study objectives
Change in Ankle Plantarflexor Strength
Change in Balance
Change in Blood Glucose
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Functional electrical stimulationExperimental Treatment2 Interventions
Participants will follow the walking program and receive stimulation assistance during the walking sessions.
Group II: ControlExperimental Treatment1 Intervention
Participants will follow the walking program.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) that target the immune system to reduce inflammation and slow disease progression, and symptomatic treatments like physical therapy and medications to manage spasticity and pain. Electrical stimulation, such as the Cionic Neural Sleeve, works by sending electrical impulses to muscles to improve muscle function and coordination. This is particularly important for MS patients as it can enhance mobility, reduce muscle stiffness, and improve overall quality of life by addressing motor deficits directly.
Robot-based rehabilitation of the upper limbs in multiple sclerosis: feasibility and preliminary results.

Find a Location

Who is running the clinical trial?

Cionic, Inc.Lead Sponsor
4 Previous Clinical Trials
116 Total Patients Enrolled
Douglas A Wajda, PhDPrincipal InvestigatorCleveland State University

Media Library

Cionic Neural Sleeve NS-100 (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05964829 — N/A
Multiple Sclerosis Research Study Groups: Control, Functional electrical stimulation
Multiple Sclerosis Clinical Trial 2023: Cionic Neural Sleeve NS-100 Highlights & Side Effects. Trial Name: NCT05964829 — N/A
Cionic Neural Sleeve NS-100 (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05964829 — N/A
~3 spots leftby Oct 2025