Transcranial Magnetic Stimulation in Children With Stroke
NCT ID: NCT01637129
Last Updated: 2014-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
4 participants
INTERVENTIONAL
2012-05-31
2013-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Magnetic Stimulation
Active Magnetic Stimulation with repetitive transcranial magnetic stimulation
Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation, repetitive at 1Hz
No Intervention
Sham Magnetic Stimulation
Sham Magnetic Stimulation
Sham Magnetic Stimulation
Interventions
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Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation, repetitive at 1Hz
Sham Magnetic Stimulation
Sham Magnetic Stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Cerebral infarction spares the transcallosal pathways.
3. Cerebral injury confirmed by brain MRI or CT
4. Ages 6-18 years inclusive.
Exclusion Criteria
2. Infarction of the cortical motor areas.
3. Presence of a brain tumor or suspected neurodegenerative disease.
4. Intractable epilepsy or a history of poorly controlled epilepsy.
5. Current use of medications that may lower seizure threshold (such as specific antipsychotics, specific antidepressants, amphetamines)
6. Hand function limited to rigid flexion or extension (score = 4 on the modified Ashworth scale)
7. Disorders causing hallucinations, delusions, or excessive anxiety or depression.
8. Pre-existing chronic pain syndromes including intractable headache and chronic daily headache.
9. Pregnancy.
10. Any sensorimotor or cognitive impairment that prevents valid responses on study measures.
11. Bilateral strokes (cerebral injuries) involving motor cortex and/or corpus callosum
12. 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).
13. Subject has had a recent neurosurgical procedure involving the brain.
14. Subject suffered traumatic brain injury that places the subject at risk of seizures.
6 Years
18 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Nationwide Children's Hospital
OTHER
Responsible Party
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Warren Lo
Associate Clinical Professor of Pediatrics and Neurology
Principal Investigators
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Warren Lo, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
The Ohio State University School of Health and Rehabilitation Sciences
Columbus, Ohio, United States
Countries
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Other Identifiers
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273611
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB11-00324
Identifier Type: -
Identifier Source: org_study_id
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