Transcranial Magnetic Stimulation in Children With Stroke (TMSCS)

This study has been completed.
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Warren Lo, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01637129
First received: June 25, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Hemiparesis
Neonatal Stroke
Ischemic Stroke
Hemorrhagic Stroke
Thrombotic Stroke
Device: Transcranial Magnetic Stimulation
Device: Sham Magnetic Stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation in Children With Stroke

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Tolerance to repetitive stimulation [ Time Frame: Up to 2 days ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Up to 2 Months ] [ Designated as safety issue: No ]

    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.



Enrollment: 4
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 25, 2012
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Paresis
Stroke
Cerebral Infarction
Intracranial Hemorrhages
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014