Transcranial Magnetic Stimulation in Children With Stroke

Phase 1

Completed

• Conditions: Hemiparesis; Neonatal Stroke; Ischemic Stroke; Hemorrhagic Stroke; Thrombotic Stroke
• Interventions: Device: Transcranial Magnetic Stimulation; Device: Sham Magnetic Stimulation

• Registration Number: NCT01637129
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic Stimulation	Transcranial Magnetic Stimulation	Active Magnetic Stimulation with repetitive transcranial magnetic stimulation
No Intervention	Sham Magnetic Stimulation	Sham Magnetic Stimulation

Primary Outcome Measures

Name	Time	Method
Tolerance to repetitive stimulation	Up to 2 days	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.

Secondary Outcome Measures

Name	Time	Method
Upper extremity strength and mobility	Up to 2 Months	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.

Trial Locations

Locations (2)

The Ohio State University School of Health and Rehabilitation Sciences; 🇺🇸 Columbus, Ohio, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States