Transcranial Magnetic Stimulation in Children With Stroke (TMSCS)

March 31, 2014 updated by: Warren Lo, Nationwide Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Collaborators

Ohio State University

Investigators

  • Principal Investigator: Warren Lo, MD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB11-00324
  • 273611 (Other Grant/Funding Number: RINCH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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