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

This study has been completed.
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Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital Identifier:
First received: May 8, 2013
Last updated: March 17, 2017
Last verified: March 2017
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 Intervention
Cerebral Palsy
Device: Transcranial Direct Current Stimulation (tDCS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Effects of tDCS in Cortical Plasticity and Motor Learning in Children With Cerebral Palsy

Resource links provided by NLM:

Further study details as provided by Felipe Fregni, Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Changes in motor assessments [ Time Frame: 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:
  • Changes in TMS measurements [ Time Frame: 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.

Enrollment: 5
Actual Study Start Date: May 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
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.
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Please refer to this study by its identifier: NCT01852474

United States, Massachusetts
Spaulding Rehabilitation Network Research Institute
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
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Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Hospital
  More Information

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital Identifier: NCT01852474     History of Changes
Other Study ID Numbers: 2012-p-000629
Study First Received: May 8, 2013
Last Updated: March 17, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
motor learning
cortical plasticity
direct current stimulation

Additional relevant MeSH terms:
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases processed this record on May 25, 2017