Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Hemiparesis Clinical Trial

— tDCS  

Official title:

Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636661
• Other study ID #: 1205M13901
• Status: Completed
• Phase: Phase 0
• First received: June 11, 2012
• Last updated: October 7, 2015
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis

Intervention

Device:
• tDCS
transcranial direct current stimulation- non-invasive brain stimulation

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Minnesota Medical Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Posttest, Follow-Up Session at One-Week	Yes
Secondary	Hand Function Decline as Measured by Number of Participants	Measured by the Box and Blocks Test and Grip Strength	Baseline, Posttest, Follow-Up Session at One-Week	Yes