Transcranial Magnetic Stimulation in Children With Stroke
Completed · Phase 1 · Has a placebo group
Conditions studied: Hemiparesis, Neonatal Stroke, Ischemic Stroke, Hemorrhagic Stroke, Thrombotic Stroke
In brief
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.
Key facts
- Study ID
- NCT01637129
- Run by
- Nationwide Children's Hospital
- People needed
- 4
- Starts
- 2012-05-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2014-04-01
Who can join
Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
- The Ohio State University School of Health and Rehabilitation Sciences — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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