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Effect of Repetitive Transcranial Magnetic Stimulation on Language in Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814697
First Posted: December 25, 2008
Last Update Posted: January 28, 2014
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):
Gayatri Devi, MD, The New York Memory Services
Results First Submitted: May 2, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Alzheimer's Disease
Aphasia
Dementia
Intervention: Device: Repetitive Transcranial Magnetic Coil Stimulation (rTMS)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients were recruited from a tertiary memory disorders practice. Patients were diagnosed as having probable or possible Alzheimer's Disease (AD), using the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria included newly diagnosed AD, pacemaker placement, a history of implanted metal object, seizures or epilepsy, a recent history of migraines, uncontrolled depression and those on medications lowering the seizure threshold.

Reporting Groups
  Description
rTMS

rTMS treatment in Alzheimer's disease

Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients


Participant Flow:   Overall Study
    rTMS
STARTED   12 
COMPLETED   12 
NOT COMPLETED   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.
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Reporting Groups
  Description
rTMS

rTMS treatment in Alzheimer's disease

Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients


Baseline Measures
   rTMS 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.1  (7.9) 
Gender 
[Units: Participants]
 
Female   5 
Male   7 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   Cognitive Assessment Task Scores Before, During and After rTMS.   [ Time Frame: 6 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gayatri Devi
Organization: The NY Memory and Healthy Aging Services
phone: 212-517-6881
e-mail: gd@nymemory.org


Publications:


Responsible Party: Gayatri Devi, MD, The New York Memory Services
ClinicalTrials.gov Identifier: NCT00814697     History of Changes
Other Study ID Numbers: 91913-5
First Submitted: December 24, 2008
First Posted: December 25, 2008
Results First Submitted: May 2, 2013
Results First Posted: January 28, 2014
Last Update Posted: January 28, 2014