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

Primary Purpose

Hemiparesis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation

Sham tDCS

Arm Description

Receiving active tDCS

tDCS equipment set to placebo setting.

Outcomes

Primary Outcome Measures

Adverse Events/Safety Assessment.
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.

Secondary Outcome Measures

Hand Function Decline as Measured by Number of Participants
Measured by the Box and Blocks Test and Grip Strength

Full Information

First Posted
June 11, 2012
Last Updated
October 7, 2015
Sponsor
University of Minnesota
Collaborators
Minnesota Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01636661
Brief Title
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Acronym
tDCS
Official Title
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Minnesota Medical Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
Receiving active tDCS
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
tDCS equipment set to placebo setting.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
transcranial direct current stimulation
Intervention Description
transcranial direct current stimulation- non-invasive brain stimulation
Primary Outcome Measure Information:
Title
Adverse Events/Safety Assessment.
Description
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.
Time Frame
Baseline, Posttest, Follow-Up Session at One-Week
Secondary Outcome Measure Information:
Title
Hand Function Decline as Measured by Number of Participants
Description
Measured by the Box and Blocks Test and Grip Strength
Time Frame
Baseline, Posttest, Follow-Up Session at One-Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Gillick, PhD, MS, PT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25413621
Citation
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.
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Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

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