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Device
Cionic Neural Sleeve for Multiple Sclerosis
N/A
Recruiting
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
Study Summary
This trial explores using a device to help people with MS manage their symptoms.
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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, week 1, week 6, week 12, post-intervention at week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, week 1, week 6, week 12, post-intervention at week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount of Daily Walking/Activity Level
Change in Fall Risk
Change in Gait Speed
+3 moreOther outcome measures
Change in Ankle Plantarflexor Strength
Change in Balance
Change in Blood Glucose
+12 moreTrial 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.
Find a Location
Who is running the clinical trial?
Cionic, Inc.Lead Sponsor
3 Previous Clinical Trials
96 Total Patients Enrolled
Douglas A Wajda, PhDPrincipal InvestigatorCleveland State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My mental ability to communicate and understand is confirmed to be adequate.I can walk for at least 15 minutes daily, with or without help.I have a condition like peripheral neuropathy that affects my muscle response.I have fallen more than once a week recently.I have a cancerous tumor in my leg that's more affected.My medications and symptoms have been stable for the last 60 days.I cannot feel my leg that is most affected.I cannot walk even with support for my ankle or knee.My mobility is moderately to severely affected by my condition.I have a blood clot in my leg that is more affected.My muscles don't respond well or tolerate stimulation.It takes me between 8 to 45 seconds to walk 25 feet.I can wear the Neural Sleeve device for up to 8 hours daily.I have a fracture or dislocation in my leg that could worsen with movement.I am between 22 and 75 years old with a form of multiple sclerosis.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Functional electrical stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is my eligibility for this clinical trial ascertainable?
"Subject to eligibility, individuals with multiple sclerosis aged between 22 and 75 can join this clinical trial. Currently, the study is aiming to enrol 6 participants in total."
Answered by AI
Is enrollment open for this research project?
"Data on clinicaltrials.gov corroborates that this study is currently searching for participants; the trial was launched September 1st 2023 and its details were most recently amended July 25th 2023."
Answered by AI
How many participants have been recruited for this research?
"Affirmative. According to clinicaltrials.gov, the medical study is still open for enrollment and was initially published on September 1st 2023 with its last update occurring on July 25th of that same year. The investigation requires 6 participants from a single trial site."
Answered by AI
Does this research endeavor accept participants who are of legal age?
"The minimum age for applicants to participate in this study is 22, and the maximum is 75. There are 42 trials specifically available for minors under 18 years of age, as well as 398 studies dedicated to individuals over 65."
Answered by AI
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