Back to resultsEffects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP)
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring motor learning, cortical plasticity, direct current stimulation
Eligibility 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.
Sites / Locations
- Spaulding Rehabilitation Network Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active tDCS
Arm Description
Subjects will receive active tDCS stimulation for 5 sessions (20m/each) over one week.
Outcomes
Primary Outcome Measures
Changes in motor assessments
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
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.
Full Information
NCT ID
NCT01852474
First Posted
May 8, 2013
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Pedal with Pete
1. Study Identification
Unique Protocol Identification Number
NCT01852474
Brief Title
Effects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP)
Official Title
Effects of tDCS in Cortical Plasticity and Motor Learning in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Pedal with Pete
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
motor learning, cortical plasticity, direct current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Subjects will receive active tDCS stimulation for 5 sessions (20m/each) over one week.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
1x1 direct current stimulator, soterix medical, transcranial stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in motor assessments
Description
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.
Time Frame
Approximately 2 weeks
Secondary Outcome Measure Information:
Title
Changes in TMS measurements
Description
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.
Time Frame
Approximately 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD PhD MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Network Research Institute
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP)
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