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

Impulsive Behavior Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805401
• Other study ID #: REB-11/42
• Secondary ID: 2012 YIA
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: October 2, 2014
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: Douglas Mental Health University Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Impulsive Behavior
• Suicidal Impulses

Intervention

Device:
• Transcranial Direct Current Stimulation
Anode placed over the OFC or the DLPFC and cathode placed over the occipital region

Locations

Country	Name	City	State
Canada	Neuromodulation Research Clinic, Douglas Mental Health University Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Beeli G, Casutt G, Baumgartner T, Jäncke 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. — View Citation

Boggio PS, Campanhã 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. — View Citation

Fecteau S, Pascual-Leone A, Zald DH, Liguori P, Théoret 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the net score of the Iowa Gambling Task		Before and after a 30-minute tDCS session	No
Secondary	Change in the "average-adjusted number of pumps" in the Balloon Analog Risk Task		Before and after a 30-minute tDCS session	No
Secondary	Change in the number of risky choices in the Game of Dice Task		Before and after a 30-minute tDCS session	No
Secondary	Change in the number of commission errors in the Continuous Performance Task		Before and after a 30-minute tDCS session	No
Secondary	Change in the interference index in the Stroop Color-Word Test		Before and after a 30-minute tDCS session	No
Secondary	Change in the stop-signal reaction time in the Stop-Signal Task		Before and after a 30-minute tDCS session	No