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Improving Rehabilitation by Magnetic Brain Stimulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00636701
First received: March 7, 2008
Last updated: April 15, 2015
Last verified: April 2015

March 7, 2008
April 15, 2015
September 2007
March 2009   (final data collection date for primary outcome measure)
Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks [ Time Frame: Baseline (day 0) and 2 weeks ] [ Designated as safety issue: No ]
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 .
WMFT [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00636701 on ClinicalTrials.gov Archive Site
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Improving Rehabilitation by Magnetic Brain Stimulation
Improving Rehabilitation by Magnetic Brain Stimulation: Improving Motor Recovery After Stroke
We hope to understand the properties of the motor cortex in the brain of people with stroke using non-invasive magnetic stimulation.
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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
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
  • 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)
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
  • 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)
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Glielmi CB, Butler AJ, Niyazov DM, Darling WG, Epstein CM, Alberts JL, Hu XP. Assessing low-frequency repetitive transcranial magnetic stimulation with functional magnetic resonance imaging: a case series. Physiother Res Int. 2014 Jun;19(2):117-25. doi: 10.1002/pri.518. Epub 2011 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
May 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636701
B4657-P
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Andrew Butler, PhD MS BA Atlanta VA Medical and Rehab Center, Decatur
VA Office of Research and Development
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP