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

This study has been completed.

Sponsor:

Collaborator:

Minnesota Medical Foundation

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT01636661

First received: June 11, 2012

Last updated: October 7, 2015

Last verified: October 2015

History of Changes

Purpose

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	Intervention	Phase
Hemiparesis	Device: tDCS	Phase 0


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Adverse Events/Safety Assessment. [ Time Frame: Baseline, Posttest, Follow-Up Session at One-Week ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Hand Function Decline as Measured by Number of Participants [ Time Frame: Baseline, Posttest, Follow-Up Session at One-Week ] [ Designated as safety issue: Yes ]
Measured by the Box and Blocks Test and Grip Strength


Enrollment:	13
Study Start Date:	July 2012
Study Completion Date:	December 2013
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Transcranial Direct Current Stimulation Receiving active tDCS	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

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.

Eligibility


Ages Eligible for Study:	8 Years to 17 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636661

Locations


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

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Minnesota Medical Foundation

Investigators


Principal Investigator:	Bernadette Gillick, PhD, MS, PT	University of Minnesota - Clinical and Translational Science Institute

More Information

Publications:

Gillick BT, Feyma T, Menk J, Usset M, Vaith A, Wood TJ, Worthington R, Krach LE. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study. Phys Ther. 2015 Mar;95(3):337-49. doi: 10.2522/ptj.20130565. Epub 2014 Nov 20.


Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT01636661 History of Changes
Other Study ID Numbers:	1205M13901
Study First Received:	June 11, 2012
Results First Received:	June 22, 2015
Last Updated:	October 7, 2015
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Paresis Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016

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