tDCS Applied to the OFC: Effects on Decision-Making and Impulse Control

NCT ID: NCT01805401

Last Updated: 2014-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy participants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this single-blind, three-arm and sham-controlled study, we will assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy volunteers. We hypothesize that tDCS applied to the OFC, in comparison to sham tDCS, will significantly enhance decision-making and impulse control. For this study we will enroll 45 healthy individuals aged 18-60 years. These individuals will be assessed with a battery of computerized tasks as well as clinician-administered and self-reported questionnaires on depression and anxiety. Assessments will be carried out before and after a single 30-minute tDCS session.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impulsive Behavior Suicidal Impulses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Left OFC Group

Anode applied to the left OFC and cathode applied to the right OFC

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Anode placed over the OFC or the DLPFC and cathode placed over the occipital region

Right OFC Group

Anode applied to the right OFC and cathode applied to the left OFC

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Anode placed over the OFC or the DLPFC and cathode placed over the occipital region

Sham tDCS

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Anode placed over the OFC or the DLPFC and cathode placed over the occipital region

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial Direct Current Stimulation

Anode placed over the OFC or the DLPFC and cathode placed over the occipital region

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

tDCS, Brain Polarization

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men or women aged 18 to 60 years

Exclusion Criteria

* Presence any psychiatric and/or neurological illness
* Psychoactive substance abuse/dependence in the past 6 months
* Current use of medication(s) that might influence cognition and/or affective status
* Presence of an uncontrolled medical disease (e.g., cardiovascular, renal)
* Pregnancy and/or lactation
* Specific contraindication for tDCS (e.g., metallic head implant).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Douglas Mental Health University Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

MARCELO T. BERLIM

Director, Neuromodulation Research Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marcelo Berlim, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Neuromodulation Research Clinic, Douglas Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Neuromodulation Research Clinic, Douglas Mental Health University Institute

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Beeli G, Casutt G, Baumgartner T, Jancke L. Modulating presence and impulsiveness by external stimulation of the brain. Behav Brain Funct. 2008 Aug 4;4:33. doi: 10.1186/1744-9081-4-33.

Reference Type BACKGROUND
PMID: 18680573 (View on PubMed)

Boggio PS, Campanha C, Valasek CA, Fecteau S, Pascual-Leone A, Fregni F. Modulation of decision-making in a gambling task in older adults with transcranial direct current stimulation. Eur J Neurosci. 2010 Feb;31(3):593-7. doi: 10.1111/j.1460-9568.2010.07080.x. Epub 2010 Jan 25.

Reference Type BACKGROUND
PMID: 20105234 (View on PubMed)

Fecteau S, Pascual-Leone A, Zald DH, Liguori P, Theoret H, Boggio PS, Fregni F. Activation of prefrontal cortex by transcranial direct current stimulation reduces appetite for risk during ambiguous decision making. J Neurosci. 2007 Jun 6;27(23):6212-8. doi: 10.1523/JNEUROSCI.0314-07.2007.

Reference Type BACKGROUND
PMID: 17553993 (View on PubMed)

Hecht D, Walsh V, Lavidor M. Transcranial direct current stimulation facilitates decision making in a probabilistic guessing task. J Neurosci. 2010 Mar 24;30(12):4241-5. doi: 10.1523/JNEUROSCI.2924-09.2010.

Reference Type BACKGROUND
PMID: 20335459 (View on PubMed)

Sela T, Kilim A, Lavidor M. Transcranial alternating current stimulation increases risk-taking behavior in the balloon analog risk task. Front Neurosci. 2012 Feb 14;6:22. doi: 10.3389/fnins.2012.00022. eCollection 2012.

Reference Type BACKGROUND
PMID: 22347844 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012 YIA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

REB-11/42

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.