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

NCT ID: NCT04725019

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2026-07-31

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).

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS + 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.

Group Type: EXPERIMENTAL

Motor training

Intervention Type: BEHAVIORAL

Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days.

active transcranial direct current stimulation

Intervention Type: DEVICE

Participants will receive 20 min of tDCS over the scalp during 20 min of motor training.

Sham tDCS + 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.

Group Type: EXPERIMENTAL

Motor training

Intervention Type: BEHAVIORAL

Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days.

Interventions

Motor training

Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days.

Intervention Type: BEHAVIORAL

active transcranial direct current stimulation

Participants will receive 20 min of tDCS over the scalp during 20 min of motor training.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Claudio

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Claudio L Ferre, PhD

Role: CONTACT

clferre@bu.edu

(617) 353-7489

Other Identifiers

5825

Identifier Type: -

Identifier Source: org_study_id