Ischemic Stroke Clinical Trial
— TMSCSOfficial title:
Transcranial Magnetic Stimulation in Children With Stroke
Verified date | March 2014 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 18 Years |
Eligibility |
Inclusion Criteria: 1. 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). 2. Cerebral infarction spares the transcallosal pathways. 3. Cerebral injury confirmed by brain MRI or CT 4. Ages 6-18 years inclusive. Exclusion Criteria: 1. The presence of an implanted device such as a pacemaker, vagal nerve stimulator, or recently implanted cardiovascular stent; arterial aneurysms; arteriovenous malformations; obstructive hydrocephalus. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | The Ohio State University School of Health and Rehabilitation Sciences | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Nationwide Children's Hospital | Ohio State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerance to repetitive stimulation | 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. |
Up to 2 days | Yes |
Secondary | Upper extremity strength and mobility | 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. |
Up to 2 Months | No |
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