NCT04725019

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2021

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Aug 2021Jul 2026

First Submitted

Initial submission to the registry

January 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

5 years

First QC Date

January 19, 2021

Last Update Submit

January 21, 2021

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Changes in Motor-evoked Potential assessment

    Day before intervention begins, compared to day after intervention ends (approximately 1 week)

Study Arms (2)

Active tDCS + motor training

EXPERIMENTAL

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 stimulationBehavioral: Motor training

Sham tDCS + motor training

EXPERIMENTAL

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

Interventions

active transcranial direct current stimulationDEVICE

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

Active tDCS + motor training
Motor trainingBEHAVIORAL

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 tDCS + motor trainingSham tDCS + motor training

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Claudio L Ferre, PhD

CONTACT

(617) 353-7489clferre@bu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 26, 2021

Study Start

August 1, 2021

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 26, 2021

Record last verified: 2021-01