Bilateral Prefrontal Modulation in Alcoholism

NCT02091284 | Completed Results

• 2 other identifiers: tDCS ALCOHOL CEP_UFES 384281CNPq_ 475232/2013-5
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, eligible alcoholic inpatients recruited from a specialized clinic for addiction treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 5 x 7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of alcohol was examined before (baseline), during and after the end of the tDCS treatment. Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change craving in alcoholism and this would be a long-lasting effect.

Conditions

Drug Addiction; Executive Dysfunction

Keywords

alcoholism; tDCS; dlPFC; craving; cognition

Outcome Measures

Primary Outcomes (1)

• Craving

  Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20. Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.

  Five applications: first week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fifth week, after the end of the tDCS treatment.

Other Outcomes (6)

• Changes in Frontal Assessment Battery (FAB) Scores

  Before tDCS treatment (initial) and after the end of the tDCS treatment (final)

• Changes in Mini-Mental Status Examination (MMSE)

  Before tDCS treatment (initial) and after the end of the tDCS treatment (final)

• Changes in Hamilton Depression Rating Scale (HAM-D)

  Before tDCS treatment (initial) and after the end of the tDCS treatment (final)

Study Arms (2)

real tDCS

EXPERIMENTAL

Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).

Device: transcranial Direct Current Stimulation

sham-tDCS

SHAM COMPARATOR

Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 20 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.

Device: transcranial Direct Current Stimulation

Interventions

transcranial Direct Current Stimulation DEVICE

Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes.

Also known as: tDCS

real tDCS; sham-tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients between the age of 18 and 60 years;
• met criteria for alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), as determined by clinical evaluation;
• in stable clinical condition with no need for inpatient care;
• able to read, write, and speak Portuguese; and
• no severe withdrawal signs or symptoms at baseline.

You may not qualify if:

• a condition of intoxication or withdrawal due to a substance other alcohol;
• unstable mental or medical disorder or substance abuse or addiction other than alcohol dependence, except nicotine and/or caffeine;
• a diagnosis of epilepsy, convulsions, or delirium tremens during abstinence from alcohol;
• a previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol;
• any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants;
• suspected pregnancy for female participants;
• any contraindication for magnetic resonance procedures such as electronic implants, metal implants, claustrophobia, or permanent make-up or tattoo received within the previous 3 months;
• the presence of vascular, traumatic, inflammatory, or tumor injuries detectable by CT examination.

Sponsors & Collaborators

• Federal University of Espirito Santo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• University of Göttingen: collaborator

Study Sites (1)

Federal University of Espírito Santo

Vitória, ES - Espírito Santo, 29060-720, Brazil

Location

Related Publications (4)

• da Silva MC, Conti CL, Klauss J, Alves LG, do Nascimento Cavalcante HM, Fregni F, Nitsche MA, Nakamura-Palacios EM. Behavioral effects of transcranial direct current stimulation (tDCS) induced dorsolateral prefrontal cortex plasticity in alcohol dependence. J Physiol Paris. 2013 Dec;107(6):493-502. doi: 10.1016/j.jphysparis.2013.07.003. Epub 2013 Jul 25.

  PMID: 23891741 BACKGROUND

• Nakamura-Palacios EM, Souza RS, Zago-Gomes MP, de Melo AM, Braga FS, Kubo TT, Gasparetto EL. Gray matter volume in left rostral middle frontal and left cerebellar cortices predicts frontal executive performance in alcoholic subjects. Alcohol Clin Exp Res. 2014 Apr;38(4):1126-33. doi: 10.1111/acer.12308. Epub 2013 Nov 20.

  PMID: 24256621 BACKGROUND

• Klauss J, Penido Pinheiro LC, Silva Merlo BL, de Almeida Correia Santos G, Fregni F, Nitsche MA, Miyuki Nakamura-Palacios E. A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence. Int J Neuropsychopharmacol. 2014 Nov;17(11):1793-803. doi: 10.1017/S1461145714000984. Epub 2014 Jul 10.

  PMID: 25008145 BACKGROUND

• Klauss J, Anders QS, Felippe LV, Nitsche MA, Nakamura-Palacios EM. Multiple Sessions of Transcranial Direct Current Stimulation (tDCS) Reduced Craving and Relapses for Alcohol Use: A Randomized Placebo-Controlled Trial in Alcohol Use Disorder. Front Pharmacol. 2018 Jul 3;9:716. doi: 10.3389/fphar.2018.00716. eCollection 2018.

  PMID: 30018558 RESULT

MeSH Terms

Conditions

Substance-Related Disorders; Alcoholism

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Ester Miyuki Nakamura-Palacios
• Organization: Federal University of Espírito Santo

emnpalacios@gmail.com

+55 27 3335-7337

Study Officials

• Ester MN Palacios, MD, PhD

  Federal University of Espírito Santo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Sham-controlled double-blind randomized trial

Study Record Dates

• First Submitted: March 16, 2014
• First Posted: March 19, 2014
• Study Start: November 1, 2013
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: August 8, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)