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Completed

NCT Number: NCT01805401

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuromodulation Research Clinic, Douglas Mental Health University Institute

Montreal, Quebec, H4H1R3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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

Other names: tDCS, Brain Polarization

Primary outcomes

  1. Change in the net score of the Iowa Gambling Task

    Time frame: Before and after a 30-minute tDCS session

Secondary outcomes

  1. Change in the "average-adjusted number of pumps" in the Balloon Analog Risk Task

    Time frame: Before and after a 30-minute tDCS session

  2. Change in the number of risky choices in the Game of Dice Task

    Time frame: Before and after a 30-minute tDCS session

  3. Change in the number of commission errors in the Continuous Performance Task

    Time frame: Before and after a 30-minute tDCS session

  4. Change in the interference index in the Stroop Color-Word Test

    Time frame: Before and after a 30-minute tDCS session

  5. Change in the stop-signal reaction time in the Stop-Signal Task

    Time frame: Before and after a 30-minute tDCS session

Sponsors and collaborators

Lead sponsor

Douglas Mental Health University Institute

Other

Registry information

Official study title

Modulating Decision-Making and Impulse Control With Transcranial Direct Current Stimulation (tDCS) Over the Orbitofrontal Cortex (OFC): A Randomized and Sham-Controlled Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2013
Registry last updated
Oct 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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