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Transcranial Magnetic Stimulation in Children With Stroke (TMSCS)

Primary Purpose

Hemiparesis, Neonatal Stroke, Ischemic Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sham Magnetic Stimulation
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis focused on measuring Childhood stroke, Perinatal stroke, Pediatric stroke, Presumed perinatal stroke, Children who have hemiparesis

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nationwide Children's Hospital
  • The Ohio State University School of Health and Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnetic Stimulation

No Intervention

Arm Description

Active Magnetic Stimulation with repetitive transcranial magnetic stimulation

Sham Magnetic Stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 25, 2012
Last Updated
March 31, 2014
Sponsor
Nationwide Children's Hospital
Collaborators
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT01637129
Brief Title
Transcranial Magnetic Stimulation in Children With Stroke
Acronym
TMSCS
Official Title
Transcranial Magnetic Stimulation in Children With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Ohio State University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Neonatal Stroke, Ischemic Stroke, Hemorrhagic Stroke, Thrombotic Stroke
Keywords
Childhood stroke, Perinatal stroke, Pediatric stroke, Presumed perinatal stroke, Children who have hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
Active Magnetic Stimulation with repetitive transcranial magnetic stimulation
Arm Title
No Intervention
Arm Type
Placebo Comparator
Arm Description
Sham Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
MagStim
Intervention Description
Transcranial Magnetic Stimulation, repetitive at 1Hz
Intervention Type
Device
Intervention Name(s)
Sham Magnetic Stimulation
Other Intervention Name(s)
MagStim
Intervention Description
Sham Magnetic Stimulation
Primary Outcome Measure Information:
Title
Tolerance to repetitive stimulation
Description
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 Outcome Measure Information:
Title
Upper extremity strength and mobility
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Cerebral infarction spares the transcallosal pathways. Cerebral injury confirmed by brain MRI or CT Ages 6-18 years inclusive. Exclusion Criteria: The presence of an implanted device such as a pacemaker, vagal nerve stimulator, or recently implanted cardiovascular stent; arterial aneurysms; arteriovenous malformations; obstructive hydrocephalus. Infarction of the cortical motor areas. Presence of a brain tumor or suspected neurodegenerative disease. Intractable epilepsy or a history of poorly controlled epilepsy. Current use of medications that may lower seizure threshold (such as specific antipsychotics, specific antidepressants, amphetamines) Hand function limited to rigid flexion or extension (score = 4 on the modified Ashworth scale) Disorders causing hallucinations, delusions, or excessive anxiety or depression. Pre-existing chronic pain syndromes including intractable headache and chronic daily headache. Pregnancy. Any sensorimotor or cognitive impairment that prevents valid responses on study measures. Bilateral strokes (cerebral injuries) involving motor cortex and/or corpus callosum 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). Subject has had a recent neurosurgical procedure involving the brain. Subject suffered traumatic brain injury that places the subject at risk of seizures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Lo, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Ohio State University School of Health and Rehabilitation Sciences
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Transcranial Magnetic Stimulation in Children With Stroke

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