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

NCT01852474 | Completed

• 1 other identifier: 2012-p-000629
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

motor learning; cortical plasticity; direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in TMS measurements

  Approximately 2 weeks

Study Arms (1)

Active tDCS

EXPERIMENTAL

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

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) 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.

Also known as: 1x1 direct current stimulator, soterix medical, transcranial stimulation

Active tDCS

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Pedal with Pete: collaborator

Study Sites (1)

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Felipe Fregni, MD PhD MPH

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 13, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)