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

Boston University Charles River Campus

Status: Not yet enrolling

Conditions: Cerebral Palsy

Treatments: Behavioral: Motor training; Device: active transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04725019

5825

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Active tDCS + motor training

Experimental group

Description:

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.

Treatment:

Behavioral: Motor training

Device: active transcranial direct current stimulation

Sham tDCS + motor training

Experimental group

Description:

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.

Treatment:

Behavioral: Motor training