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Clinical Trials/NCT01852474
NCT01852474CompletedNot Applicable

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

Spaulding Rehabilitation Hospital2 sites in 1 country5 target enrollmentStarted: May 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
5
Locations
2
Primary Endpoint
Changes in motor assessments

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • Changes in TMS measurements(Approximately 2 weeks)

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Felipe Fregni

Principal Investigator

Spaulding Rehabilitation Hospital

Study Sites (2)

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