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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


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
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