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

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ClinicalTrials.gov Identifier: NCT00814697
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : January 28, 2014
Last Update Posted : January 28, 2014
Sponsor:
Information provided by (Responsible Party):
Gayatri Devi, MD, The New York Memory Services

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)
Enrollment 12

Recruitment Details 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 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.
Arm/Group Title rTMS
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rTMS treatment in Alzheimer's disease

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

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title rTMS
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rTMS treatment in Alzheimer's disease

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

Overall Number of Baseline Participants 12
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  25.0%
>=65 years
9
  75.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
73.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Cognitive Assessment Task Scores Before, During and After rTMS.
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Cognitive assessment tasks - Boston Diagnostic Aphasia Examination (BDAE), CFL Category naming (CFL), Mini-Mental State Examination (MMSE) - were administered and scored according to standard procedures before, during and 4 weeks after rTMS.

Higher scores are associated with better cognition; No absolute cut-offs were used here as the outcomes were not categorically assessed.

Total possible score ranges by test, lowest to highest:

BDAE - 0 to 15 CFL - 0 to 62 MMSE - 0 to 30 Full range data and means presented below represents range of scores at 4-weeks post-rTMS treatments.

Time Frame 6 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Assessment
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rTMS treatment in Alzheimer's disease

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

Overall Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: units on a scale
Mini-Mental State Examination (MMSE)
26.9
(19 to 30)
Boston Diagnostic Aphasia Examination (BDAE)
13.3
(9 to 15)
CFL Category Fluency
17.0
(8 to 32)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rTMS
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rTMS treatment in Alzheimer's disease

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

All-Cause Mortality
rTMS
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
rTMS
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rTMS
Affected / at Risk (%)
Total   0/12 (0.00%) 
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
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