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Completed

NCT Number: NCT01636661

Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

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.

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Key information

Conditions

Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

transcranial direct current stimulation- non-invasive brain stimulation

Other names: transcranial direct current stimulation

Primary outcomes

  1. Adverse Events/Safety Assessment.

    Time frame: 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:

    • 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.

Secondary outcomes

  1. Hand Function Decline as Measured by Number of Participants

    Time frame: Baseline, Posttest, Follow-Up Session at One-Week

    Measured by the Box and Blocks Test and Grip Strength

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Minnesota Medical Foundation

Registry information

Acronym: tDCS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2012
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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