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CompletedNCT01637129TMSCSUpdated Apr 1, 2014

Transcranial Magnetic Stimulation in Children With Stroke

A Phase 1 interventional study of Transcranial Magnetic Stimulation and Sham Magnetic Stimulation in Hemiparesis, Neonatal Stroke and Ischemic Stroke, sponsored by Nationwide Children's Hospital. Completed at 2 sites in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-04-01.

Sponsored by Nationwide Children's Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Childhood stroke
  • Perinatal stroke
  • Pediatric stroke
  • Presumed perinatal stroke
  • Children who have hemiparesis
03

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4 participants (actual)

Study arms

  • Active comparator
    Magnetic Stimulation

    Active Magnetic Stimulation with repetitive transcranial magnetic stimulation

    Device: Transcranial Magnetic Stimulation

  • Placebo comparator
    No Intervention

    Sham Magnetic Stimulation

    Device: Sham Magnetic Stimulation

Interventions

  • DeviceTranscranial Magnetic Stimulation

    Transcranial Magnetic Stimulation, repetitive at 1Hz

    Also known as: MagStim

  • DeviceSham Magnetic Stimulation

    Sham Magnetic Stimulation

    Also known as: MagStim

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 days

Secondary outcomes

  1. 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.

    Time frame: Up to 2 Months

06

Study locations

2 sites
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
  • The Ohio State University School of Health and Rehabilitation Sciences
    Columbus, Ohio 43210, United States
07

Registry details

Key details

Study ID
NCT01637129
Lead sponsor
Nationwide Children's Hospital
Collaborators
Ohio State University
Responsible party
Warren Lo (Associate Clinical Professor of Pediatrics and Neurology, Nationwide Children's Hospital) — Principal investigator
First posted
Jul 10, 2012
Start date
May 2012
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Apr 1, 2014

Study contacts

Warren Lo, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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