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Effects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP)

Sponsor
Spaulding Rehabilitation Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01852474
Collaborator
Pedal with Pete (Other)
5
Enrollment
1
Location
1
Arm
36
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators aim to assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy. Investigators will use different assessment techniques, such as transcranial magnetic stimulation (TMS) and kinematics (sensors) to measure changes through the trial.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Direct Current Stimulation (tDCS)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of tDCS in Cortical Plasticity and Motor Learning in Children With Cerebral Palsy
Actual Study Start Date :
May 1, 2013
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active tDCS

Subjects will receive active tDCS stimulation for 5 sessions (20m/each) over one week.

Device: Transcranial Direct Current Stimulation (tDCS)
Subjects will receive tDCS stimulation 1x per day for 5 days (over the period of 1 week). Each session will be 20 minutes long. The subject will receive active stimulation for the entire 20 minutes.
Other Names:
  • 1x1 direct current stimulator
  • soterix medical
  • transcranial stimulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in motor assessments [Approximately 2 weeks]

      Investigators will measure changes in kinematic (sensor) assessments from baseline to follow-up. The sensor will collect Inertial Measurements Units (IMU) and complex motion sensing, as measured by accelerometer/gyroscope/magnetometer of freedom motion capture.

    Secondary Outcome Measures

    1. Changes in TMS measurements [Approximately 2 weeks]

      Investigators will measure change in TMS measurements from baseline to follow-up. TMS measures will consist of: motor threshold, motor evoked potentials (MEP's), transcallosal inhibition, and examinations of intracortical inhibition and facilitation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age of participants must be between 8 and 18 years old.

    • Diagnosis of spastic or mixed CP with distribution of diplegia and/or hemiplegia form.

    • Gross Motor Function Classification System for Cerebral Palsy (GMFCS) level II and III.

    • Manual Ability Classification System for Children with CP (MACS) level II up to IV.

    • Ability to cooperate and follow directions.

    Exclusion Criteria:

    • Muscle tone reduction therapy in the past 3 months prior to study onset.

    • Upper limb orthopedic surgery in the past 3 months prior to study onset.

    • Any other form of therapy or procedure involving motor neuron junction inhibition; either by biochemical and/or mechanical denervation, in the past 3 months prior to study onset.

    • History of convulsive disorder in the past 2 years prior to study onset.

    • Current use of carbamazepine as anticonvulsive therapy.

    • Presence ventriculoperitoneal shunt.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spaulding Rehabilitation Network Research Institute Charlestown Massachusetts United States 02129

    Sponsors and Collaborators

    • Spaulding Rehabilitation Hospital
    • Pedal with Pete

    Investigators

    • Principal Investigator: Felipe Fregni, MD PhD MPH, Spaulding Rehabilitation Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
    ClinicalTrials.gov Identifier:
    NCT01852474
    Other Study ID Numbers:
    • 2012-p-000629
    First Posted:
    May 13, 2013
    Last Update Posted:
    Apr 24, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
    motor learning
    cortical plasticity
    direct current stimulation
    Additional relevant MeSH terms:
    Cerebral Palsy

    Study Results

    No Results Posted as of Apr 24, 2020