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| ID | Type | Description | Link |
|---|---|---|---|
| 273611 | Other Grant/Funding Number | RINCH |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Stimulation | Active Comparator | Active Magnetic Stimulation with repetitive transcranial magnetic stimulation |
|
| No Intervention | Placebo Comparator | Sham Magnetic Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Transcranial Magnetic Stimulation, repetitive at 1Hz |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Lo, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States | ||
| The Ohio State University School of Health and Rehabilitation Sciences |
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| ID | Term |
|---|---|
| D010291 | Paresis |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D000083244 | Thrombotic Stroke |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham Magnetic Stimulation | Device | Sham Magnetic Stimulation |
|
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |