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

Cerebral Palsy Clinical Trial

Official title:

Effects of tDCS in Cortical Plasticity and Motor Learning in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852474
• Other study ID #: 2012-p-000629
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Network Research Institute	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Pedal with Pete

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 2 weeks
Secondary	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.	Approximately 2 weeks