Transcranial Magnetic Stimulation in Children With Stroke (TMSCS)

Nationwide Children's Hospital

Status and phase: Completed; Phase 1

Conditions: Ischemic Stroke; Thrombotic Stroke; Hemorrhagic Stroke; Hemiparesis; Neonatal Stroke

Treatments: Device: Transcranial Magnetic Stimulation; Device: Sham Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01637129

IRB11-00324

273611 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

4 participants in 2 patient groups, including a placebo group

Magnetic Stimulation

Active Comparator group

Description:

Active Magnetic Stimulation with repetitive transcranial magnetic stimulation

Treatment:

Device: Transcranial Magnetic Stimulation

No Intervention

Placebo Comparator group

Description:

Sham Magnetic Stimulation

Treatment:

Device: Sham Magnetic Stimulation