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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: active transcranial direct current stimulation; Behavioral: Motor training

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudio L Ferre, PhD; Phone Number: (617) 353-7489; Email: clferre@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: active transcranial direct current stimulation; Participants will receive 20 min of tDCS over the scalp during 20 min of motor training.; Behavioral: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): July 31, 2026
• Study Completion (Anticipated): July 31, 2026

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 5825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If the study is funded by National Institute of Health (NIH), the investigators will share individual participant data (IPD) via the NIH Data Hub (DASH), which is sponsored by the National Institute of Child Health and Development (NICHD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No