TMSCS: Transcranial Magnetic Stimulation in Children With Stroke

Sponsor

Nationwide Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01637129

Collaborator

Ohio State University (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiparesis Neonatal Stroke Ischemic Stroke Hemorrhagic Stroke Thrombotic Stroke	Device: Transcranial Magnetic Stimulation Device: Sham Magnetic Stimulation	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Transcranial Magnetic Stimulation in Children With Stroke

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Magnetic Stimulation Active Magnetic Stimulation with repetitive transcranial magnetic stimulation	Device: Transcranial Magnetic Stimulation Transcranial Magnetic Stimulation, repetitive at 1Hz Other Names: MagStim
Placebo Comparator: No Intervention Sham Magnetic Stimulation	Device: Sham Magnetic Stimulation Sham Magnetic Stimulation Other Names: MagStim

Arm

Intervention/Treatment

Active Comparator: Magnetic Stimulation

Active Magnetic Stimulation with repetitive transcranial magnetic stimulation

Device: Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation, repetitive at 1Hz

Other Names:

MagStim

Placebo Comparator: No Intervention

Sham Magnetic Stimulation

Device: Sham Magnetic Stimulation

Sham Magnetic Stimulation

Other Names:

MagStim

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
2	The Ohio State University School of Health and Rehabilitation Sciences	Columbus	Ohio	United States	43210