NCT01637129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

June 25, 2012

Last Update Submit

March 31, 2014

Conditions

HemiparesisNeonatal StrokeIschemic StrokeHemorrhagic StrokeThrombotic Stroke

Keywords

Childhood strokePerinatal strokePediatric strokePresumed perinatal strokeChildren who have hemiparesis

Outcome Measures

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.

    Up to 2 days

Secondary Outcomes (1)

  • Upper extremity strength and mobility

    Up to 2 Months

Study Arms (2)

Magnetic Stimulation

ACTIVE COMPARATOR

Active Magnetic Stimulation with repetitive transcranial magnetic stimulation

Device: Transcranial Magnetic Stimulation

No Intervention

PLACEBO COMPARATOR

Sham Magnetic Stimulation

Device: Sham Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE

Transcranial Magnetic Stimulation, repetitive at 1Hz

Also known as: MagStim
Magnetic Stimulation
Sham Magnetic StimulationDEVICE

Sham Magnetic Stimulation

Also known as: MagStim
No Intervention

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Ohio State University School of Health and Rehabilitation Sciences

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

ParesisIschemic StrokeHemorrhagic StrokeThrombotic Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Warren Lo, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor of Pediatrics and Neurology

Study Record Dates

First Submitted

June 25, 2012

First Posted

July 10, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

US(2)