Improving Rehabilitation by Magnetic Brain Stimulation

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00636701
First received: March 7, 2008
Last updated: May 7, 2009
Last verified: May 2009

March 7, 2008
May 7, 2009
September 2007
March 2009   (final data collection date for primary outcome measure)
WMFT [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00636701 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
Device: Repetitive Transcranial Magnetic Stimulation
We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes
  • Experimental: 1
    Receive rTMS
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
  • Placebo Comparator: 2
    Receive sham rTMS
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636701
B4657P
No
Butler, Andrew - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Andrew Butler, PhD MS BA Atlanta VA Medical and Rehab Center, Decatur
Department of Veterans Affairs
May 2009

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