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Behavioral Intervention
tDCS + CIMT for Cerebral Palsy
N/A
Waitlist Available
Led By Yanlong Song, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
5-17 years of age, including 5-year-old and 17-year-old
Formal diagnosis of hemiplegic cerebral palsy
Must not have
Less than five years of age and older than 17 years of age
Brain surgery, peripheral nerve surgery, genetic disorders, other neurological disorders or injuries
Timeline
Screening 3 weeks
Treatment Varies
Follow Up with the first day of the intervention defined as day 1, this measure will be assessed in one of the three days before day 1, on day 15 or day 16 or day 17, and on day 181 or day 182 or day 183.
Summary
This trial aims to test if using transcranial direct current stimulation (tDCS) can improve the effectiveness of constraint-induced movement therapy (CIMT) in children with HCP. They also
Who is the study for?
This trial is for children with Hemiplegic Cerebral Palsy (HCP), a condition affecting one side of the body. Participants should be able to follow instructions and attend multiple therapy sessions. Children with metal in their head, skin conditions on the scalp, seizures, or those who can't tolerate having their stronger arm restrained are excluded.
What is being tested?
The study is testing whether tDCS (a non-invasive brain stimulation technique) can improve how well constraint-induced movement therapy (CIMT) works for improving motor skills in kids with HCP. Some will receive real tDCS while others get a sham treatment as part of the research design.
What are the potential side effects?
tDCS may cause mild discomfort, itching, tingling or a burning sensation on the scalp during application. There's also a small risk of fatigue or headache after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 5 and 17 years old.
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I have been diagnosed with hemiplegic cerebral palsy.
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I have movement and feeling issues in one arm and hand.
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I can undergo study procedures by myself.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am older than 17 and younger than 5 years old.
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I have had brain or nerve surgery, or I have a genetic or other neurological disorder.
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I am unable to understand or follow study instructions.
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I am not taking any psychoactive or muscle relaxant medications during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ with the first day of the intervention defined as day 1, this measure will be assessed in one of the three days before day 1, on day 15 or day 16 or day 17, and on day 181 or day 182 or day 183.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~with the first day of the intervention defined as day 1, this measure will be assessed in one of the three days before day 1, on day 15 or day 16 or day 17, and on day 181 or day 182 or day 183.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
fine manual dexterity
gross manual dexterity
Secondary study objectives
finger touch sensitivity
quality of upper extremity skill
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: tDCS+CIMTExperimental Treatment2 Interventions
Participants will receive concurrent anodal tDCS (20 minutes, 1mA\~2mA) and CIMT (2 hours) five days a week for three weeks in a row.
Group II: sham+CIMTPlacebo Group2 Interventions
Participants will receive concurrent sham tDCS and CIMT (2 hours) five days a week for three weeks in a row.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~630
CIMT
2021
N/A
~90
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,081 Previous Clinical Trials
1,056,273 Total Patients Enrolled
11 Trials studying Stroke
3,258 Patients Enrolled for Stroke
Children's HealthOTHER
7 Previous Clinical Trials
431 Total Patients Enrolled
Yanlong Song, PhDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
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