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Completed

NCT Number: NCT01637129

Transcranial Magnetic Stimulation in Children With Stroke

This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal stroke.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nationwide Children's Hospital, Columbus, Ohio, United States

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About this study

The investigators will begin to test the hypothesis that rTMS will be tolerated and will result in improved hand strength and mobility when compared with sham stimulation.

Aim 1: To determine whether 1 Hz rTMS applied to the hemisphere opposite the infarct (contralesional or healthy hemisphere) is tolerated by children ages 6-18 years who have chronic motor sequelae from a stroke.

Aim 2: To determine whether 8 sessions of inhibitory 1 Hz rTMS to the contralesional healthy hemisphere improves grip strength and hand mobility when compared with sham stimulation in controls.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A history of ischemic or hemorrhagic stroke at least 6 months prior to recruitment, and causing current unilateral motor impairment of hand function (scoring 1-3 on a modified Ashworth scale; scale explained in Appendix).
  • Cerebral infarction spares the transcallosal pathways.
  • Cerebral injury confirmed by brain MRI or CT
  • Ages 6-18 years inclusive.

Exclusion criteria

  • The presence of an implanted device such as a pacemaker, vagal nerve stimulator, or recently implanted cardiovascular stent; arterial aneurysms; arteriovenous malformations; obstructive hydrocephalus.
  • Infarction of the cortical motor areas.
  • Presence of a brain tumor or suspected neurodegenerative disease.
  • Intractable epilepsy or a history of poorly controlled epilepsy.
  • Current use of medications that may lower seizure threshold (such as specific antipsychotics, specific antidepressants, amphetamines)
  • Hand function limited to rigid flexion or extension (score = 4 on the modified Ashworth scale)
  • Disorders causing hallucinations, delusions, or excessive anxiety or depression.
  • Pre-existing chronic pain syndromes including intractable headache and chronic daily headache.
  • Pregnancy.
  • Any sensorimotor or cognitive impairment that prevents valid responses on study measures.
  • Bilateral strokes (cerebral injuries) involving motor cortex and/or corpus callosum
  • All patients and parents must be naïve regarding the effects and sensations of rTMS (i.e., patients and/or parents with prior exposure to TMS will be excluded).
  • Subject has had a recent neurosurgical procedure involving the brain.
  • Subject suffered traumatic brain injury that places the subject at risk of seizures.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Transcranial Magnetic Stimulation, repetitive at 1Hz

Other names: MagStim

Sham magnetic stimulation

Device

Sham Magnetic Stimulation

Other names: MagStim

Primary outcomes

  1. Tolerance to repetitive stimulation

    Time frame: Up to 2 days

    The patient's reports of side effects recorded on the CRF at each session will be tabulated and the pre-stimulation scores will be subtracted from the post-stimulation scores.

    Cognitive function will be assessed with 6 measures (Executive Function / Spatial Problem Solving, Psychomotor Function / Speed of Processing, Visual Attention / Vigilance, Visual Learning & Memory, Verbal Learning & Memory, and Attention / Working Memory measures). As with the tolerance assessments, we will tabulate before-stimulation and after-stimulation assessments and analyze the difference.

Secondary outcomes

  1. Upper extremity strength and mobility

    Time frame: Up to 2 Months

    Upper extremity strength will be assessed with a Jtech dynamometer at three different locations: elbow extension (triceps), elbow flexion (biceps), and grip.

    Joint mobility at the elbow and wrist will be assessed with the modified Ashworth score.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • Ohio State University

Registry information

Acronym: TMSCS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2012
Registry last updated
Apr 1, 2014

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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