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NCT Number: NCT01852474

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 1x1 direct current stimulator, soterix medical, transcranial stimulation

Primary outcomes

  1. Changes in motor assessments

    Time frame: 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 outcomes

  1. Changes in TMS measurements

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Pedal with Pete

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 13, 2013
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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