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Clinical Trials/NCT04725019
NCT04725019
Not yet recruiting
Not Applicable

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

Boston University Charles River Campus0 sites60 target enrollmentAugust 1, 2021
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Boston University Charles River Campus
Enrollment
60
Primary Endpoint
Changes in the Box and Blocks test
Status
Not yet recruiting
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
July 31, 2026
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Principal Investigator
Principal Investigator

Claudio

Assistant Professor

Boston University Charles River Campus

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

Outcomes

Primary Outcomes

Changes in the Box and Blocks test

Time Frame: 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

Time Frame: 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 Outcomes

  • Changes in Motor-evoked Potential assessment(Day before intervention begins, compared to day after intervention ends (approximately 1 week))

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