Transcranial Magnetic Stimulation in Children With Stroke

Ischemic Stroke Clinical Trial

— TMSCS  

Official title:

Transcranial Magnetic Stimulation in Children With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637129
• Other study ID #: IRB11-00324
• Secondary ID: 273611
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2012
• Last updated: March 31, 2014
• Start date: May 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis
• Hemorrhagic Stroke
• Ischemic Stroke
• Neonatal Stroke
• Stroke
• Thrombotic Stroke

Intervention

Device:
• Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation, repetitive at 1Hz
• Sham Magnetic Stimulation
Sham Magnetic Stimulation

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	The Ohio State University School of Health and Rehabilitation Sciences	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No