NCT01330394

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 27, 2013

Completed
Last Updated

December 24, 2013

Status Verified

September 1, 2013

Enrollment Period

2.1 years

First QC Date

April 5, 2011

Results QC Date

September 24, 2013

Last Update Submit

November 26, 2013

Conditions

Alcohol DependenceExecutive DysfunctionAbnormal Craving for Drugs

Keywords

AlcoholismLesch's typologytDCSERPP300FABMMSECognitive tasks

Outcome Measures

Primary Outcomes (1)

  • Use of Alcohol

    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).

    6 months after treatment

Secondary Outcomes (4)

  • Event-related Potentials

    one year and a half

  • Cognitive Tasks

    one year and a half

  • Quality of Life

    one year and a half

  • Effort to Control the Urge for Use Alcohol

    one year and a half

Study Arms (2)

sham-tDCS control

SHAM COMPARATOR

simulate control for transcranial Direct Current Stimulation

Device: transcranial Direct Current Stimulation

active tDCS

ACTIVE COMPARATOR

active transcranial Direct Current Stimulation

Device: transcranial Direct Current Stimulation

Interventions

transcranial Direct Current StimulationDEVICE

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.

Also known as: non-invasive brain stimulation
active tDCSsham-tDCS control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Diagnosis of other drug dependence, except nicotine and caffeine use;
  • Diagnosis of other mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Federal University of Espírito Santo

Vitória, Espírito Santo, 29.042-755, Brazil

Location

Laboratory of Cognitive Sciences and Neuropsychopharmacology, Post-Graduation Program in Physiologycal Sciences, Health Sciences Center, Federal University of Espírito Santo

Vitória, Espírito Santo, 29042-755, Brazil

Location

Related Publications (13)

  • Zago-Gomes Mda P, Nakamura-Palacios EM. Cognitive components of frontal lobe function in alcoholics classified according to Lesch's typology. Alcohol Alcohol. 2009 Sep-Oct;44(5):449-57. doi: 10.1093/alcalc/agp043. Epub 2009 Aug 8.

    PMID: 19666906BACKGROUND

  • Goldstein RZ, Volkow ND. Drug addiction and its underlying neurobiological basis: neuroimaging evidence for the involvement of the frontal cortex. Am J Psychiatry. 2002 Oct;159(10):1642-52. doi: 10.1176/appi.ajp.159.10.1642.

    PMID: 12359667BACKGROUND

  • Moselhy HF, Georgiou G, Kahn A. Frontal lobe changes in alcoholism: a review of the literature. Alcohol Alcohol. 2001 Sep-Oct;36(5):357-68. doi: 10.1093/alcalc/36.5.357.

    PMID: 11524299BACKGROUND

  • Lesch OM, Dietzel M, Musalek M, Walter H, Zeiler K. The course of alcoholism. Long-term prognosis in different types. Forensic Sci Int. 1988 Jan;36(1-2):121-38. doi: 10.1016/0379-0738(88)90225-3.

    PMID: 3338683BACKGROUND

  • Lesch OM, Kefer J, Lentner S, Mader R, Marx B, Musalek M, Nimmerrichter A, Preinsberger H, Puchinger H, Rustembegovic A, et al. Diagnosis of chronic alcoholism--classificatory problems. Psychopathology. 1990;23(2):88-96. doi: 10.1159/000284644.

    PMID: 2259714BACKGROUND

  • Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

    PMID: 20633386BACKGROUND

  • Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

    PMID: 10990547BACKGROUND

  • Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.

    PMID: 11723286BACKGROUND

  • BINDMAN LJ, LIPPOLD OC, REDFEARN JW. THE ACTION OF BRIEF POLARIZING CURRENTS ON THE CEREBRAL CORTEX OF THE RAT (1) DURING CURRENT FLOW AND (2) IN THE PRODUCTION OF LONG-LASTING AFTER-EFFECTS. J Physiol. 1964 Aug;172(3):369-82. doi: 10.1113/jphysiol.1964.sp007425. No abstract available.

    PMID: 14199369BACKGROUND

  • PURPURA DP, MCMURTRY JG. INTRACELLULAR ACTIVITIES AND EVOKED POTENTIAL CHANGES DURING POLARIZATION OF MOTOR CORTEX. J Neurophysiol. 1965 Jan;28:166-85. doi: 10.1152/jn.1965.28.1.166. No abstract available.

    PMID: 14244793BACKGROUND

  • Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.

    PMID: 15999258BACKGROUND

  • Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.

    PMID: 15753425BACKGROUND

  • Nitsche MA, Liebetanz D, Antal A, Lang N, Tergau F, Paulus W. Modulation of cortical excitability by weak direct current stimulation--technical, safety and functional aspects. Suppl Clin Neurophysiol. 2003;56:255-76. doi: 10.1016/s1567-424x(09)70230-2. No abstract available.

    PMID: 14677403BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Dr. Ester Miyuki Nakamura-Palacios
Organization
Federal University of Espírito Santo
emnpalacios@gmail.com
+55 27 7775-7337

Study Officials

  • Ester M Nakamura-Palacios, MD, PhD

    Federal University of Espírito Santo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 7, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 24, 2013

Results First Posted

November 27, 2013

Record last verified: 2013-09

Locations

BR(2)