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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Assisting Hand Assessment

Secondary study objectives

Box and Blocks test

Jebsen-Taylor Test of Hand Function

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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