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Transcranial Magnetic Stimulation in Children With Stroke (TMSCS)

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ClinicalTrials.gov Identifier: NCT01637129
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : April 1, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 2012
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: MagStim
Placebo Comparator: No Intervention
Sham Magnetic Stimulation
Device: Sham Magnetic Stimulation
Sham Magnetic Stimulation
Other Name: MagStim


Outcome Measures

Primary Outcome Measures :
  1. Tolerance to repetitive stimulation [ Time Frame: 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 :
  1. Upper extremity strength and mobility [ Time Frame: 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

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637129


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
The Ohio State University School of Health and Rehabilitation Sciences
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Nationwide Children's Hospital
Ohio State University
Investigators
Principal Investigator: Warren Lo, MD Nationwide Children's Hospital
More Information

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 ( Other Grant/Funding Number: RINCH )
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by Warren Lo, Nationwide Children's Hospital:
Childhood stroke
Perinatal stroke
Pediatric stroke
Presumed perinatal stroke
Children who have hemiparesis

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms