Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Kimie Suemoto, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01481558
First received: November 21, 2011
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: March 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Apathy
Alzheimer's Disease
Intervention: Device: Transcranial direct current stimulation

  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
Dates of recruitment: January 2012 to May 2012 Location: Outpatient dementia clinic

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
Sham Transcranial Direct Current Stimulation One application of sham tDCS every two days (total: 6 applications)
Transcranial Direct Current Stimulation One application of tDCS every two days (total: 6 applications)

Participant Flow:   Overall Study
    Sham Transcranial Direct Current Stimulation     Transcranial Direct Current Stimulation  
STARTED     20     20  
COMPLETED     20     20  
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
Sham Transcranial Direct Current Stimulation One application of sham tDCS every two days (total: 6 applications)
Transcranial Direct Current Stimulation One application of tDCS every two days (total: 6 applications)
Total Total of all reporting groups

Baseline Measures
    Sham Transcranial Direct Current Stimulation     Transcranial Direct Current Stimulation     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     1     2  
>=65 years     19     19     38  
Age  
[units: years]
Mean ± Standard Deviation
  81.6  ± 8.0     79.4  ± 7.1     80.5  ± 7.5  
Gender  
[units: participants]
     
Female     13     15     28  
Male     7     5     12  
Region of Enrollment  
[units: participants]
     
Brazil     20     20     40  



  Outcome Measures

1.  Primary:   Apathy Symptoms   [ Time Frame: Differences in outcome measure comparing second week to baseline ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Claudia Kimie Suemoto
Organization: University of Sao Paulo
phone: 551130618249
e-mail: cksuemoto@usp.br


No publications provided


Responsible Party: Claudia Kimie Suemoto, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01481558     History of Changes
Other Study ID Numbers: 0679/11
Study First Received: November 21, 2011
Results First Received: March 20, 2013
Last Updated: December 9, 2013
Health Authority: Brazil: Ethics Committee