Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy
• Interventions: Device: active transcranial direct current stimulation; Behavioral: Motor training

• Registration Number: NCT04725019
• Lead Sponsor: Boston University Charles River Campus

Brief Summary

The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Study First Posted: 2021-01-26
• Last Update Posted: 2021-01-26
• Study Start: 2021-08-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions.

Exclusion Criteria

• Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
• True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen
• Current use of medications known to lower the seizure threshold
• Previous episode of unprovoked neurocardiogenic syncope
• Indwelling metal or incompatible medical devices
• Centrally-acting medications including anti-seizure medications
• Evidence of scalp disease or skin abnormalities
• Current medical illness unrelated to CP
• High motor ability in affected arm (i.e. no asymmetry in scores of hand function)
• Severe spasticity
• Lack of asymmetry in hand function
• Orthopedic surgery in affected arm
• Botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period
• Currently receiving intrathecal baclofen
• History of broken arm (either arm) 1 year prior to study enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS + motor training	active transcranial direct current stimulation	In this arm, participants will receive 20 minutes of active tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games.
Active tDCS + motor training	Motor training	In this arm, participants will receive 20 minutes of active tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games.
Sham tDCS + motor training	Motor training	In this arm, participants will receive 20 minutes of sham tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. Children receiving sham tDCS will wear the tDCS device but not receive active stimulation.

Primary Outcome Measures

Name	Time	Method
Changes in the Box and Blocks test	Day before intervention begins, compared to day after intervention ends (approximately 1 week)	Investigators will measure changes in the movement speed of the hands.
Changes in the Assisting Hand Assessment	Day before intervention begins, compared to day after intervention ends (approximately 1 week)	Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities.

Secondary Outcome Measures

Name	Time	Method
Changes in Motor-evoked Potential assessment	Day before intervention begins, compared to day after intervention ends (approximately 1 week)	Investigators will measure change in measurements of cortical excitability using transcranial magnetic stimulation (TMS) from baseline to follow-up (1 week).