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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01852474
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : April 24, 2020
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Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

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
Cerebral Palsy Device: Transcranial Direct Current Stimulation (tDCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01852474

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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
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Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital Identifier: NCT01852474    
Other Study ID Numbers: 2012-p-000629
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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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:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases