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Device
tDCS for Childhood Stroke (TOPSS Trial)
N/A
Recruiting
Led By Stuart M Fraser, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Affected arm Fugl-Meyer score of 60 or lower
Childhood stroke survivor - either arterial ischemic stroke or intracerebral hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,1 week post therapy , 3 month post therapy assessment
Awards & highlights
TOPSS Trial Summary
This trial investigates if a non-invasive brain stimulation technique (tDCS) combined with occupational therapy can help improve arm function in childhood stroke survivors.
Who is the study for?
This trial is for children and teens who had a stroke, either from a blocked artery or bleeding in the brain, between 29 days old to 18 years. They should be at least 3 months post-stroke with some arm weakness but able to do therapy sessions. It's not for those with recent seizures, missing skull pieces (unless repaired), or metal implants in the head.Check my eligibility
What is being tested?
The study tests how well kids tolerate Transcranial Direct Current Stimulation (tDCS) and if it helps improve arm function when combined with occupational therapy after surviving a stroke.See study design
What are the potential side effects?
Possible side effects of tDCS may include discomfort at the electrode site on the scalp, itching, tingling during stimulation, headache, fatigue, nausea or other mild complaints.
TOPSS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My arm's movement is significantly limited.
Select...
I survived a stroke as a child.
TOPSS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline,1 week post therapy , 3 month post therapy assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,1 week post therapy , 3 month post therapy assessment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of patients who complete the study
Secondary outcome measures
Change in quality of unilateral upper limb movement as assessed by the Melbourne Assessment of the Upper Extremity (MUUL)
Change in tolerability as assessed by the percent of patients that endorse mild side effects as documented on the stimulation monitoring sheet
Change in tolerability as assessed by the percent of patients with hypotension or hypertension on blood pressure monitoring
+2 moreSide effects data
From 2018 Phase 2 trial • 54 Patients • NCT017266733%
back pain flair up
3%
Myasthenia Gravis
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS + Robotic Arm Therapy
tDCS Sham + Robotic Arm Therapy
TOPSS Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcranial Direct Current Stimulation (tDCS)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~2100
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,955 Total Patients Enrolled
Stuart M Fraser, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke between 29 days old and 18 years old.It has been over 3 months since I had a stroke.You have metal implants in your head or devices that could be affected by tDCS, such as a cochlear implant or brain stimulator.You have limited movement or weakness in your arm due to a previous stroke.My arm's movement is significantly limited.I have not had a seizure in the last 6 months.I had surgery to remove part of my skull and haven't had the bone replaced.I survived a stroke as a child.I can take part in occupational therapy sessions.
Research Study Groups:
This trial has the following groups:- Group 1: Transcranial Direct Current Stimulation (tDCS)
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 this clinical experiment actively seeking participants?
"Information on clinicaltrials.gov states that this particular medical trial is not actively enrolling participants at present. The experiment was initially posted in June 1st of 2023, and has been amended most recently as April 11th of the same year; however, there are over a thousand other active trials seeking applicants right now."
Answered by AI
Does this experiment necessitate participants of a minimum age of 20?
"To join this trial, prospective participants must be between 5 and 19 years old. Furthermore, there are 39 studies that cater to younger individuals while 1013 offer treatment options for those above the age of 65."
Answered by AI
Is it possible for me to become a participant in this trial?
"Appropriate candidates for this trial should have a history of stroke during childhood and be aged between 5-19. At present, the study is actively looking to enrol approximately 5 participants."
Answered by AI
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