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Improving Rehabilitation by Magnetic Brain Stimulation

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ClinicalTrials.gov Identifier: NCT00636701
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : May 1, 2015
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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

Condition or disease Intervention/treatment Phase
Stroke Device: Repetitive Transcranial Magnetic Stimulation Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Rehabilitation by Magnetic Brain Stimulation: Improving Motor Recovery After Stroke
Study Start Date : September 2007
Primary Completion Date : March 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Primed rTMS
Receive 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
Device: Repetitive Transcranial Magnetic Stimulation
We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
Other Name: RTMS
Placebo Comparator: Unprimed rTMS)
Receive 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
Device: Repetitive Transcranial Magnetic Stimulation
We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
Other Name: RTMS



Primary Outcome Measures :
  1. 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 .



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636701


Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Andrew Butler, PhD MS BA Atlanta VA Medical and Rehab Center, Decatur

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00636701     History of Changes
Other Study ID Numbers: B4657-P
First Posted: March 14, 2008    Key Record Dates
Results First Posted: May 1, 2015
Last Update Posted: May 1, 2015
Last Verified: April 2015

Keywords provided by VA Office of Research and Development:
Cerebrovascular Accident
rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases