Early Phase 1 N=11 Randomized Triple-blind Treatment

Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Hemiparesis

Bottom Line

View on ClinicalTrials.gov: NCT01636661 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Adverse Events/Safety Assessment. — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: tDCS (Device)
Age: Pediatric · 8+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events/Safety Assessment.	0; 0; 0; 0; 0; 0	—
SECONDARY Hand Function Decline as Measured by Number of Participants	0; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01636661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.