Overview

This trial is active, not recruiting.

Condition cerebral palsy
Treatment transcranial direct current stimulation (tdcs)
Phase phase 2
Sponsor Spaulding Rehabilitation Hospital
Collaborator Pedal with Pete
Start date May 2013
End date January 2017
Trial size 5 participants
Trial identifier NCT01852474, 2012-p-000629

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects will receive active tDCS stimulation for 5 sessions (20m/each) over one week.
transcranial direct current stimulation (tdcs) 1x1 direct current stimulator
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 Outcomes

Measure
Changes in motor assessments
time frame: Approximately 2 weeks

Secondary Outcomes

Measure
Changes in TMS measurements
time frame: Approximately 2 weeks

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

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.

Additional Information

Official title Effects of tDCS in Cortical Plasticity and Motor Learning in Children With Cerebral Palsy
Principal investigator Felipe Fregni, MD PhD MPH
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.