Clinical trial NCT01805401: tDCS Applied to the OFC: Effects on Decision-Making and Impulse Control
Official title: Modulating Decision-Making and Impulse Control With Transcranial Direct Current Stimulation (tDCS) Over the Orbitofrontal Cortex (OFC): A Randomized and Sham-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impulsive Behavior
Suicidal Impulses
Keywords: Decision-making
Impulse control
Transcranial direct current stimulation
Brain stimulation
Neuromodulation
tDCS
Iowa Gambling Task
Stroop Word-Color Task
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in the net score of the Iowa Gambling Task
timeFrame: Before and after a 30-minute tDCS session
Secondary outcomes:
measure: Change in the "average-adjusted number of pumps" in the Balloon Analog Risk Task
timeFrame: Before and after a 30-minute tDCS session
measure: Change in the number of risky choices in the Game of Dice Task
timeFrame: Before and after a 30-minute tDCS session
measure: Change in the number of commission errors in the Continuous Performance Task
timeFrame: Before and after a 30-minute tDCS session
measure: Change in the interference index in the Stroop Color-Word Test
timeFrame: Before and after a 30-minute tDCS session
measure: Change in the stop-signal reaction time in the Stop-Signal Task
timeFrame: Before and after a 30-minute tDCS session
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Neuromodulation Research Clinic, Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: Neuromodulation Research Clinic, Douglas Institute
name: Marcelo Berlim, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.