Clinical trial NCT01636661: Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Official title: Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hemiparesis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Minnesota Medical Foundation
First posted: 2012-07-10
Enrollment: 13
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events/Safety Assessment.
timeFrame: Baseline, Posttest, Follow-Up Session at One-Week
Secondary outcomes:
measure: Hand Function Decline as Measured by Number of Participants
timeFrame: Baseline, Posttest, Follow-Up Session at One-Week
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Bernadette Gillick, PhD, MS, PT
role: PRINCIPAL_INVESTIGATOR
References:
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.