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

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active transcranial direct current stimulation
Motor training
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Active tDCS + motor training

    Sham tDCS + motor training

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in the Assisting Hand Assessment
    Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities.
    Changes in the Box and Blocks test
    Investigators will measure changes in the movement speed of the hands.

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    January 19, 2021
    Last Updated
    January 21, 2021
    Sponsor
    Boston University Charles River Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04725019
    Brief Title
    Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation
    Official Title
    Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    July 31, 2026 (Anticipated)
    Study Completion Date
    July 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Boston University Charles River Campus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active tDCS + motor training
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Sham tDCS + motor training
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    active transcranial direct current stimulation
    Intervention Description
    Participants will receive 20 min of tDCS over the scalp during 20 min of motor training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motor training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in the Assisting Hand Assessment
    Description
    Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities.
    Time Frame
    Day before intervention begins, compared to day after intervention ends (approximately 1 week)
    Title
    Changes in the Box and Blocks test
    Description
    Investigators will measure changes in the movement speed of the hands.
    Time Frame
    Day before intervention begins, compared to day after intervention ends (approximately 1 week)
    Secondary Outcome Measure Information:
    Title
    Changes in Motor-evoked Potential assessment
    Description
    Investigators will measure change in measurements of cortical excitability using transcranial magnetic stimulation (TMS) from baseline to follow-up (1 week).
    Time Frame
    Day before intervention begins, compared to day after intervention ends (approximately 1 week)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Claudio L Ferre, PhD
    Phone
    (617) 353-7489
    Email
    clferre@bu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing 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).

    Learn more about this trial

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

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