Transcranial Magnetic Stimulation in Children With Stroke (TMSCS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemiparesis Neonatal Stroke Ischemic Stroke Hemorrhagic Stroke Thrombotic Stroke |
Device: Transcranial Magnetic Stimulation Device: Sham Magnetic Stimulation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Transcranial Magnetic Stimulation in Children With Stroke |
- Tolerance to repetitive stimulation [ Time Frame: Up to 2 days ] [ Designated as safety issue: Yes ]
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.
- Upper extremity strength and mobility [ Time Frame: Up to 2 Months ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Magnetic Stimulation
Active Magnetic Stimulation
|
Device: Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation, repetitive at 1Hz
Other Name: MagStim
|
|
Placebo Comparator: No Intervention
Sham Magnetic Stimulation
|
Device: Sham Magnetic Stimulation
Sham Magnetic Stimulation
Other Name: MagStim
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Karen Carter | (614) 722-2526 | Karen.Carter@nationwidechildrens.org |
| Contact: Warren Lo, MD | 614-722-4625 | Warren.Lo@nationwidechildrens.org |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Principal Investigator: Warren Lo, MD | |
| The Ohio State University School of Health and Rehabilitation Sciences | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Jill Heathcock, PhD Jill.Heathcock@osumc.edu | |
| Principal Investigator: | Warren Lo, MD | Nationwide Children's Hospital |
More Information
No publications provided
| Responsible Party: | Warren Lo, Associate Clinical Professor of Pediatrics and Neurology, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01637129 History of Changes |
| Other Study ID Numbers: | IRB11-00324, 273611 |
| Study First Received: | June 25, 2012 |
| Last Updated: | July 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nationwide Children's Hospital:
|
Childhood stroke Perinatal stroke Pediatric stroke Presumed perinatal stroke Children who have hemiparesis |
Additional relevant MeSH terms:
|
Paresis Stroke Cerebral Infarction Intracranial Hemorrhages Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013