Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Alcoholism

This study has been completed.
Sponsor:
Collaborators:
Harvard University
University of Göttingen
Information provided by (Responsible Party):
Ester Miyuki Nakamura-Palacios, Federal University of Espirito Santo
ClinicalTrials.gov Identifier:
NCT01330394
First received: April 5, 2011
Last updated: November 26, 2013
Last verified: September 2013
Results First Received: September 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
Executive Dysfunction
Abnormal Craving for Drugs
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
35 alcoholic subjects were recruited between October 2012 and January 2013 in diverse public outpatient services specialized in mental health

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-tDCS Control simulate control for bilateral transcranial Direct Current Stimulation on the left and right dorsolateral prefrontal cortex
Active tDCS active transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 2 mA, double 13 min stimulation with 20 min interval between them) was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex once a day for 5 consecutive days

Participant Flow:   Overall Study
    Sham-tDCS Control     Active tDCS  
STARTED     17     16  
COMPLETED     17     16  
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-tDCS Control simulate control for transcranial Direct Current Stimulation
Active tDCS active transcranial Direct Current Stimulation
Total Total of all reporting groups

Baseline Measures
    Sham-tDCS Control     Active tDCS     Total  
Number of Participants  
[units: participants]
  17     16     33  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     16     33  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.5  ± 8.9     44.0  ± 7.8     44.1  ± 8.6  
Gender  
[units: participants]
     
Female     1     0     1  
Male     16     16     32  
Region of Enrollment  
[units: participants]
     
Brazil     17     16     33  



  Outcome Measures

1.  Primary:   Use of Alcohol   [ Time Frame: 6 months after treatment ]

2.  Secondary:   Event-related Potentials   [ Time Frame: one year and a half ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Cognitive Tasks   [ Time Frame: one year and a half ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Quality of Life   [ Time Frame: one year and a half ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Effort to Control the Urge for Use Alcohol   [ Time Frame: one year and a half ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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. Ester Miyuki Nakamura-Palacios
Organization: Federal University of Espírito Santo
phone: +55 27 7775-7337
e-mail: emnpalacios@gmail.com


Publications:


Responsible Party: Ester Miyuki Nakamura-Palacios, Federal University of Espirito Santo
ClinicalTrials.gov Identifier: NCT01330394     History of Changes
Other Study ID Numbers: FAPES45397090/09
Study First Received: April 5, 2011
Results First Received: September 24, 2013
Last Updated: November 26, 2013
Health Authority: Brazil: Ethics Committee