Transcranial Magnetic Stimulation in Children With Stroke
Ключові слова
Анотація
Опис
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.
Дати
Востаннє перевірено: | 02/28/2014 |
Перший поданий: | 06/24/2012 |
Орієнтовна реєстрація подана: | 07/08/2012 |
Опубліковано вперше: | 07/09/2012 |
Останнє оновлення надіслано: | 03/30/2014 |
Останнє оновлення опубліковано: | 03/31/2014 |
Фактична дата початку навчання: | 04/30/2012 |
Розрахункова дата первинного завершення: | 07/31/2013 |
Розрахункова дата завершення дослідження: | 07/31/2013 |
Стан або захворювання
Втручання / лікування
Device: Magnetic Stimulation
Device: No Intervention
Фаза
Групи рук
Рука | Втручання / лікування |
---|---|
Active Comparator: Magnetic Stimulation Active Magnetic Stimulation with repetitive transcranial magnetic stimulation | Device: Magnetic Stimulation Transcranial Magnetic Stimulation, repetitive at 1Hz |
Placebo Comparator: No Intervention Sham Magnetic Stimulation | Device: No Intervention Sham Magnetic Stimulation |
Критерії прийнятності
Вік, придатний для навчання | 6 Years До 6 Years |
Стать, яка підходить для вивчення | All |
Приймає здорових добровольців | Так |
Критерії | 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. |
Результат
Заходи первинного результату
1. Tolerance to repetitive stimulation [Up to 2 days]
Заходи вторинного результату
1. Upper extremity strength and mobility [Up to 2 Months]