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
  Purpose

Alcohol dependency is the most frequent addiction leading to a massive burden of both, patients health, and economy. Present therapeutic concepts suffer from limited efficacy, and thus new innovative therapies are needed. Neuroscientific studies have shown that prefrontal function in alcohol-dependent patients is impaired, leading to cognitive disturbances, and continuation of dependent behaviour. The results of pilot studies demonstrate that activation of prefrontal cortices via non-invasive brain stimulation improves cognitive performance in healthy subjects, and diminishes dependency-related behaviour in patients. The investigators aim to develop a stimulation protocol suited to induce a clinically relevant improvement of prefrontal functions in patients suffering from alcohol dependency. Therefore, the investigators will develop stimulation protocols which are able to modulate prefrontal activation for a much longer time course than those currently available, and will explore if the induced physiological alterations translate to respective cognitive improvements and reduction of addictive behaviour.


Condition Intervention Phase
Alcohol Dependence
Executive Dysfunction
Abnormal Craving for Drugs
Device: transcranial Direct Current Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Alcoholism Treatment by Cognitive Neuromodulation Produced by Repeated Transcranial Direct Current Stimulation Over the Left Dorsolateral Prefrontal Cortex

Resource links provided by NLM:


Further study details as provided by Federal University of Espirito Santo:

Primary Outcome Measures:
  • Use of Alcohol [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    Relapse to the use of alcohol to a usual pattern observed before treatment (for example, if a patient was used to have 10 drinks/day before treatment and start to have about this amount of drinks/day with similar behavior seen before treatment, it would be considered a relapse).


Secondary Outcome Measures:
  • Event-related Potentials [ Time Frame: one year and a half ] [ Designated as safety issue: No ]
    Event-related potential (ERPs) was recorded under the presentation of 120 sounds [60 of 3 types related to the use of alcoholic beverages (open a can of beer, fill a glass of beer, opening and fall of the lid of a bottle of beer), and 3 types of 60 neutral sounds (open a door, typing a keyboard, shower water)] lasted for 384 s for each period before and after transcranial Direct Current Stimulation

  • Cognitive Tasks [ Time Frame: one year and a half ] [ Designated as safety issue: No ]
    Cognitive tests comprised by Frontal Assessment Battery (FAB), verbal n-back task, visuospatial n-back task, go-no-go task, counting Stroop, will be done at the beginning of the session 1 and session 6 (one week after the 5 sessions of sham or tDCS).

  • Quality of Life [ Time Frame: one year and a half ] [ Designated as safety issue: No ]
    Quality of life scale will be applied at the end of the protocol

  • Effort to Control the Urge for Use Alcohol [ Time Frame: one year and a half ] [ Designated as safety issue: No ]
    Obsessive Compulsive Drinking Scale will be applied before and after ERP procedures


Enrollment: 33
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: sham-tDCS control
simulate control for transcranial Direct Current Stimulation
Device: transcranial Direct Current Stimulation
transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 1 mA, during 10 min) will be applied over the left dorsolateral prefrontal cortex once a week for 5 consecutive weeks.
Other Name: non-invasive brain stimulation
Active Comparator: active tDCS
active transcranial Direct Current Stimulation
Device: transcranial Direct Current Stimulation
transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 1 mA, during 10 min) will be applied over the left dorsolateral prefrontal cortex once a week for 5 consecutive weeks.
Other Name: non-invasive brain stimulation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with diagnosis confirmed by Diagnostic and Statistical Manual of Mental Disorders in its Fourth Edition (DSM-IV);
  • Alcoholics classified as type IV according to Lesch's Typology.
  • 18-65 years old from both genders;
  • clinically stable and not requiring hospitalization;
  • with significant history of consumption of at least 35 weekly doses of alcohol on average last year;
  • and an active intake of at least 35 weekly doses of alcohol in the last 90 days before starting the study;
  • being in a minimum of seven days of abstinence until beginning of the study protocol;
  • able to read, write and speak Portuguese.

Exclusion Criteria:

  • Diagnosis of other drug dependence, except nicotine and caffeine use;
  • Diagnosis of other mental disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330394

Locations
Brazil
Federal University of Espírito Santo
Vitória, Espírito Santo, Brazil, 29.042-755
Laboratory of Cognitive Sciences and Neuropsychopharmacology, Post-Graduation Program in Physiologycal Sciences, Health Sciences Center, Federal University of Espírito Santo
Vitória, Espírito Santo, Brazil, 29042-755
Sponsors and Collaborators
Federal University of Espirito Santo
Harvard University
University of Göttingen
Investigators
Principal Investigator: Ester M Nakamura-Palacios, MD, PhD Federal University of Espírito Santo
  More Information

Publications:

Responsible Party: Ester Miyuki Nakamura-Palacios, MD, PhD, 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

Keywords provided by Federal University of Espirito Santo:
Alcoholism
Lesch's typology
tDCS
ERP
P300
FAB
MMSE
Cognitive tasks

Additional relevant MeSH terms:
Alcoholism
Pica
Alcohol-Related Disorders
Chemically-Induced Disorders
Eating Disorders
Feeding and Eating Disorders of Childhood
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 20, 2014