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Improving Rehabilitation by Magnetic Brain Stimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636701
First Posted: March 14, 2008
Last Update Posted: May 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: November 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Intervention: Device: Repetitive Transcranial Magnetic Stimulation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1

Receive rTMS (Repetitive Transcranial Magnetic Stimulation)

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

Arm 2

Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)

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


Participant Flow:   Overall Study
    Arm 1   Arm 2
STARTED   2   2 
COMPLETED   2   2 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1

Receive rTMS (Repetitive Transcranial Magnetic Stimulation)

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

Arm 2

Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)

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

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   4 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   2   2   4 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   1   1   2 
Male   1   1   2 
Region of Enrollment 
[Units: Participants]
     
United States   2   2   4 


  Outcome Measures

1.  Primary:   Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks   [ Time Frame: Baseline (day 0) and 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Andrew Butler
Organization: Atlanta VA Medical Center
phone: 404-413-1415
e-mail: andrewbutler@gsu.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00636701     History of Changes
Other Study ID Numbers: B4657-P
First Submitted: March 7, 2008
First Posted: March 14, 2008
Results First Submitted: November 20, 2014
Results First Posted: May 1, 2015
Last Update Posted: May 1, 2015