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

NCT ID: NCT01852474

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active tDCS

Subjects will receive active tDCS stimulation for 5 sessions (20m/each) over one week.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

1x1 direct current stimulator; soterix medical; transcranial 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pedal with Pete

UNKNOWN

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, United States

Countries

United States

Other Identifiers

2012-p-000629

Identifier Type: -

Identifier Source: org_study_id