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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: Transcranial Direct Current Stimulation (tDCS)

• Registration Number: NCT01852474
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-13
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active tDCS	Transcranial Direct Current Stimulation (tDCS)	Subjects will receive active tDCS stimulation for 5 sessions (20m/each) over one week.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Spaulding Rehabilitation Network Research Institute; 🇺🇸 Charlestown, Massachusetts, United States