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Device

tDCS + Bimanual Therapy for Cerebral Palsy

N/A

Recruiting

Led By Kathleen M Friel, PhD

Research Sponsored by Burke Medical Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of congenital hemiplegic cerebral palsy

Ability to lift and grasp light objects with affected hand

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day before intervention begins, compared to day after intervention ends (six days after intervention begins)

Awards & highlights

Study Summary

This trial will test if a new brain stimulation treatment can improve hand function in children with USCP. Children will be randomly assigned to either receive the new treatment or a fake (sham) treatment.

Who is the study for?

This trial is for children with unilateral spastic cerebral palsy who can follow instructions, lift and grasp light objects with the affected hand, and extend their wrist at least 15 degrees. Parents must consent. Children who've had selective dorsal rhizotomy or seizures after age 2 are excluded.Check my eligibility

What is being tested?

The study tests if active transcranial direct current stimulation (tDCS) combined with bimanual training improves hand function in these children compared to a sham tDCS plus bimanual training. Participants will be randomly assigned to one of these two groups.See study design

What are the potential side effects?

Possible side effects of tDCS may include mild tingling, itching or discomfort at the electrode site on the scalp, fatigue, headache, nausea or irritability. These are typically temporary and resolve soon after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with congenital hemiplegic cerebral palsy.

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I can pick up and hold light objects with my affected hand.

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I can bend my wrist 15 degrees.

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I can understand and follow study instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day before intervention begins, compared to day after intervention ends (six days after intervention begins)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day before intervention begins, compared to day after intervention ends (six days after intervention begins)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day before intervention begins, compared to day after intervention ends (six days after intervention begins) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Assisting Hand Assessment

Secondary outcome measures

Box and Blocks test

Jebsen-Taylor Test of Hand Function

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham tDCS + bimanual trainingExperimental Treatment1 Intervention

In this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will wear the tDCS device that is worn by the active tDCS group, but in the sham group, participants will not receive stimulation during this 20 min period.

Group II: Active tDCS + bimanual trainingExperimental Treatment2 Interventions

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaOTHER

1,379 Previous Clinical Trials

1,588,412 Total Patients Enrolled

5 Trials studying Cerebral Palsy

4,530 Patients Enrolled for Cerebral Palsy

Teachers College, Columbia UniversityOTHER

24 Previous Clinical Trials

5,777 Total Patients Enrolled

6 Trials studying Cerebral Palsy

293 Patients Enrolled for Cerebral Palsy

Burke Medical Research InstituteLead Sponsor

23 Previous Clinical Trials

1,385 Total Patients Enrolled

4 Trials studying Cerebral Palsy

178 Patients Enrolled for Cerebral Palsy

Media Library

Active tDCS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03402854 — N/A

Cerebral Palsy Research Study Groups: Sham tDCS + bimanual training, Active tDCS + bimanual training

Cerebral Palsy Clinical Trial 2023: Active tDCS Highlights & Side Effects. Trial Name: NCT03402854 — N/A

Active tDCS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03402854 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the clinical trial capped at?

"Affirmative. According to clinicaltrials.gov, this trial is actively enrolling potential participants; the study was posted on December 1st 2019 and last updated October 2nd 2022. Eighty individuals need to be selected from a single medical centre for participation in the research project."

Answered by AI

Are individuals below 35 years of age eligible for participation in this research?

"This research requires participants to have a minimum age of 8 and maximum of 18, as specified by the given admission criteria."

Answered by AI

Are prospective volunteers currently being accepted for this trial?

"Clinicaltrials.gov reports that this medical investigation is actively accepting participants, with the initial posting being on December 1st 2019 and a most recent edit occurring October 2nd 2022."

Answered by AI

Am I eligible to volunteer for this clinical research?

"This medical trial is seeking 80 individuals with cerebral palsy between 8 and 18 years of age."

Answered by AI

Who else is applying?

What site did they apply to?

Burke Medical Research Institute

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

This is actually for my son,his name is Gerald,he is 8 years old,and we're looking for treatment for him to get better,caring for him is difficult for us as a family as he gets older,we're constrained because of very little finances.We love him and want him to lead a normal or almost normal life.Thats the overall motivation for searching the internet and reaching out to you here.

PatientReceived 2+ prior treatments