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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Spaulding Rehabilitation Hospital
Sponsor:
Collaborator:
Pedal with Pete
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01852474
First received: May 8, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Phase
Cerebral Palsy
Device: Transcranial Direct Current Stimulation (tDCS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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 Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Changes in motor assessments [ Time Frame: Approximately 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 42
Study Start Date: May 2013
Estimated Primary Completion Date: May 2015 (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. During active stimulation, the subject will receive stimulation for the entire 20 minutes. For Sham stimulation, the stimulation will be active only for a short time, but will remain on the scalp for the duration of 20 minutes. Both active and sham stimulation will feel the same.
Other Names:
  • 1x1 direct current stimulator
  • soterix medical
  • transcranial stimulation
Placebo Comparator: Sham tDCS
Subjects will receive sham 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. During active stimulation, the subject will receive stimulation for the entire 20 minutes. For Sham stimulation, the stimulation will be active only for a short time, but will remain on the scalp for the duration of 20 minutes. Both active and sham stimulation will feel the same.
Other Names:
  • 1x1 direct current stimulator
  • soterix medical
  • transcranial stimulation

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852474

Contacts
Contact: Felipe Fregni, MD PhD MPH 617-952-6156 ffregni@partners.org
Contact: Kayleen M Weaver, BA 617-952-6151 kmweaver@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Network Research Institute Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Felipe Fregni, MD PhD MPH    617-952-6156    ffregni@partners.org   
Contact: Kayleen M Weaver, BA    617-952-6151    kmweaver@partners.org   
Principal Investigator: Felipe Fregni, MD PhD MPH         
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Pedal with Pete
Investigators
Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01852474     History of Changes
Other Study ID Numbers: 2012-p-000629
Study First Received: May 8, 2013
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014