Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

NCT01636661 | Completed Early Phase 1 Results

• 1 other identifier: 1205M13901
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. 1.tDCS will not produce a major adverse event, including seizure activity.
2. 2.No change in paretic or nonparetic hand function or cognitive status will occur.

Conditions

Hemiparesis

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  Baseline, Posttest, Follow-Up Session at One-Week

Secondary Outcomes (1)

• Hand Function Decline as Measured by Number of Participants

  Baseline, Posttest, Follow-Up Session at One-Week

Study Arms (2)

Transcranial Direct Current Stimulation

EXPERIMENTAL

Receiving active tDCS

Device: tDCS

Sham tDCS

SHAM COMPARATOR

tDCS equipment set to placebo setting.

Device: tDCS

Interventions

tDCS DEVICE

transcranial direct current stimulation- non-invasive brain stimulation

Also known as: transcranial direct current stimulation

Sham tDCS; Transcranial Direct Current Stimulation

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Minnesota Medical Foundation: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related 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: 10.2522/ptj.20130565. Epub 2014 Nov 20.

  PMID: 25413621 RESULT

MeSH Terms

Conditions

Paresis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Bernadette Gillick
• Organization: University of Minnesota

brown029@umn.edu

612.626.6415

Study Officials

• Bernadette Gillick, PhD, MS, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 9, 2015
• Results First Posted: July 20, 2015

Record last verified: 2015-10

Locations

US (1)