Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS)
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ClinicalTrials.gov Identifier: NCT01636661 |
Recruitment Status :
Completed
First Posted : July 10, 2012
Results First Posted : July 20, 2015
Last Update Posted : November 9, 2015
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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:
- tDCS will not produce a major adverse event, including seizure activity.
- No change in paretic or nonparetic hand function or cognitive status will occur.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemiparesis | Device: tDCS | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Transcranial Direct Current Stimulation
Receiving active tDCS
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Device: tDCS
transcranial direct current stimulation- non-invasive brain stimulation
Other Name: 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 Name: transcranial direct current stimulation |
- 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:
- Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.
- Physician Evaluation- Child identified as declining in function from pretest to posttest.
- Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.
Detailed adverse events are reported in the adverse events module.
- 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

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Ages Eligible for Study: | 8 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.
- Hemispheric Stroke or Periventricular Leukomalacia
- Ages 8-17 years old
- ≥ 10 degrees of active motion at the metacarpophalangeal joint
- Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
- No evidence of seizure activity within the last 2 years.
- 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:
- Metabolic Disorders
- Neoplasm
- Epilepsy
- Disorders of Cellular Migration and Proliferation
- Acquired Traumatic Brain Injury
- Expressive Aphasia
- Pregnancy
- Indwelling metal or incompatible medical devices
- Evidence of skin disease or skin abnormalities
- Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636661
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Bernadette Gillick, PhD, MS, PT | University of Minnesota |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT01636661 |
Other Study ID Numbers: |
1205M13901 |
First Posted: | July 10, 2012 Key Record Dates |
Results First Posted: | July 20, 2015 |
Last Update Posted: | November 9, 2015 |
Last Verified: | October 2015 |
Paresis Neurologic Manifestations Nervous System Diseases |