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Clinical Trials/NCT00636701
NCT00636701
Completed
Phase 1

Improving Rehabilitation by Magnetic Brain Stimulation: Improving Motor Recovery After Stroke

US Department of Veterans Affairs1 site in 1 country4 target enrollmentSeptember 2007
ConditionsStroke

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stroke
Sponsor
US Department of Veterans Affairs
Enrollment
4
Locations
1
Primary Endpoint
Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

We hope to understand the properties of the motor cortex in the brain of people with stroke using non-invasive magnetic stimulation.

Detailed Description

This case series assesses the effects of five consecutive days of low-frequency (1 Hz) repetitive transcranial magnetic stimulation (rTMS) with and without a 6-Hz primer. Although this paper studies able-bodied individuals, similar rTMS protocols are used to facilitate motor recovery in patients with hemiplegia following stroke. However, the cortical mechanisms associated with repeated daily doses of rTMS are not completely understood.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
May 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 3-24 months post stroke
  • upper limb paresis
  • CES-D below 16,

Exclusion Criteria

  • history of seizure
  • metal in head
  • score of less than 24 on the Folstein Mini-Mental Status Exam
  • clinical judgement of excessive frailty or lack of stamina (e.g. cannot attend to instructions, stay awake, engage in functional activities)
  • serious uncontrolled medical condition
  • excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention as judged by the examining clinician

Outcomes

Primary Outcomes

Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks

Time Frame: Baseline (day 0) and 2 weeks

Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .

Study Sites (1)

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