Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Early Phase 1

Completed

• Conditions: Hemiparesis
• Interventions: Device: tDCS

• Registration Number: NCT01636661
• Lead Sponsor: University of Minnesota

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:

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-06-11
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Results First Submitted: 2015-06-22
• Results First Submitted QC: 2015-06-22
• Results First Posted: 2015-07-20
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	tDCS	tDCS equipment set to placebo setting.
Transcranial Direct Current Stimulation	tDCS	Receiving active tDCS

Primary Outcome Measures

Name	Time	Method
Adverse Events/Safety Assessment.	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.

Secondary Outcome Measures

Name	Time	Method
Hand Function Decline as Measured by Number of Participants	Baseline, Posttest, Follow-Up Session at One-Week	Measured by the Box and Blocks Test and Grip Strength

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States