Your session is about to expire
← Back to Search
Neuromodulation
Neuromodulation + Balance Training for Stroke
N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score < 34).
At least six months since the onset of Ischemic or hemorrhagic stroke.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks
Awards & highlights
Study Summary
This trial will assess if a tongue stimulator combined with balance training can help improve walking & posture after stroke.
Who is the study for?
This trial is for individuals who had a stroke at least six months ago, have some weakness in their legs, can walk 10 feet with or without help, and score below certain levels on balance and walking tests. They must be able to understand the study's risks and benefits. People with other neurological issues, recent strokes in the opposite brain hemisphere, severe joint problems, tongue sensation loss, metal dental work they can't remove, or those pregnant cannot join.Check my eligibility
What is being tested?
The study is testing if a device called Portable Neuromodulation Stimulator (PoNS), which stimulates the brain through the tongue to improve balance when used alongside gait and balance training exercises. Some participants will receive PoNS while others get a sham device as part of the research.See study design
What are the potential side effects?
Since PoNS involves non-invasive stimulation of the tongue there may be minimal side effects such as discomfort at the site of stimulation. The exact side effects are not detailed but are expected to be mild given the nature of neuromodulation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have weakness in my leg(s) as measured by a specific test.
Select...
It has been over 6 months since I had a stroke.
Select...
I have difficulty walking.
Select...
I can walk at least 10 feet by myself or with help like a cane.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment and post-treatment following four weeks of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment and post-treatment following four weeks of intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in balance
Change in gait speed
Secondary outcome measures
Change in Postural balance
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Portable Neuromodulation StimulatorExperimental Treatment2 Interventions
Group II: ShamPlacebo Group2 Interventions
Find a Location
Who is running the clinical trial?
Brooks RehabilitationOTHER
13 Previous Clinical Trials
1,693 Total Patients Enrolled
1 Trials studying Stroke
38 Patients Enrolled for Stroke
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,575 Total Patients Enrolled
67 Trials studying Stroke
59,991 Patients Enrolled for Stroke
Steven Kautz, PhDStudy ChairMedical University of South Carolina
2 Previous Clinical Trials
24 Total Patients Enrolled
2 Trials studying Stroke
24 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have weakness in my leg(s) as measured by a specific test.I have a long-term infectious disease.It has been over 6 months since I had a stroke.I understand the risks and benefits of joining the study.I have severe arthritis or orthopedic issues limiting my movement.I have a neurological disorder.You have metal braces that cannot be taken out.You have issues with your teeth or mouth.I do not have any recent bleeding or open wounds.I had a stroke in the opposite side of my brain before.I have difficulty walking.You cannot feel things normally on your tongue.I can walk at least 10 feet by myself or with help like a cane.I have undergone cancer treatment within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Portable Neuromodulation Stimulator
- Group 2: Sham
Awards:
This trial has 0 awards, including: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.
Are there still opportunities for participants in this trial?
"It appears that this medical trial is still open to participants as per the information presented on clinicaltrials.gov; it was originally posted on August 28th 2023 and last edited a day later."
Answered by AI
Is the enrolment for this trial restricted to individuals over sixty years old?
"According to the requirements for this medical trial, potential participants must be between ages 22 and 85. For those under 18 years old there are 36 studies they can take part in whereas 1044 trials cater specifically to individuals over 65."
Answered by AI
How many participants are engaging in this research endeavor?
"Verifiably, clinicaltrials.gov confirms that this medical research is actively recruiting volunteers. This trial was first published on August 28th 2023 and underwent its most recent update a day later. The study needs to enroll 60 patients from one particular site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger