Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS)

October 7, 2015 updated by: University of Minnesota

The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.

The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:

  1. tDCS will not produce a major adverse event, including seizure activity.
  2. No change in paretic or nonparetic hand function or cognitive status will occur.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.
  2. Hemispheric Stroke or Periventricular Leukomalacia
  3. Ages 8-17 years old
  4. ≥ 10 degrees of active motion at the metacarpophalangeal joint
  5. Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
  6. No evidence of seizure activity within the last 2 years.
  7. Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature.

Exclusion Criteria:

  1. Metabolic Disorders
  2. Neoplasm
  3. Epilepsy
  4. Disorders of Cellular Migration and Proliferation
  5. Acquired Traumatic Brain Injury
  6. Expressive Aphasia
  7. Pregnancy
  8. Indwelling metal or incompatible medical devices
  9. Evidence of skin disease or skin abnormalities
  10. Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Direct Current Stimulation
Receiving active tDCS
Device: tDCS
transcranial direct current stimulation- non-invasive brain stimulation
Other Names:
  • transcranial direct current stimulation
Sham Comparator: Sham tDCS
tDCS equipment set to placebo setting.
Device: tDCS
transcranial direct current stimulation- non-invasive brain stimulation
Other Names:
  • transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events/Safety Assessment.
Time Frame: Baseline, Posttest, Follow-Up Session at One-Week

Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:

  1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.
  2. Physician Evaluation- Child identified as declining in function from pretest to posttest.
  3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.

Detailed adverse events are reported in the adverse events module.
Baseline, Posttest, Follow-Up Session at One-Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Function Decline as Measured by Number of Participants
Time Frame: Baseline, Posttest, Follow-Up Session at One-Week
Measured by the Box and Blocks Test and Grip Strength
Baseline, Posttest, Follow-Up Session at One-Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Minnesota Medical Foundation

Investigators

  • Principal Investigator: Bernadette Gillick, PhD, MS, PT, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

November 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1205M13901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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