NCT01805401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 6, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

January 16, 2013

Last Update Submit

October 2, 2014

Conditions

Impulsive BehaviorSuicidal Impulses

Keywords

Decision-makingImpulse controlTranscranial direct current stimulationBrain stimulationNeuromodulationtDCSIowa Gambling TaskStroop Word-Color Task

Outcome Measures

Primary Outcomes (1)

  • Change in the net score of the Iowa Gambling Task

    Before and after a 30-minute tDCS session

Secondary Outcomes (5)

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

    Before and after a 30-minute tDCS session

  • Change in the number of risky choices in the Game of Dice Task

    Before and after a 30-minute tDCS session

  • Change in the number of commission errors in the Continuous Performance Task

    Before and after a 30-minute tDCS session

  • Change in the interference index in the Stroop Color-Word Test

    Before and after a 30-minute tDCS session

  • Change in the stop-signal reaction time in the Stop-Signal Task

    Before and after a 30-minute tDCS session

Study Arms (3)

Left OFC Group

EXPERIMENTAL

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

Device: Transcranial Direct Current Stimulation

Right OFC Group

EXPERIMENTAL

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

Device: Transcranial Direct Current Stimulation

Sham tDCS

SHAM COMPARATOR
Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current StimulationDEVICE

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

Also known as: tDCS, Brain Polarization
Left OFC GroupRight OFC GroupSham tDCS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men or women aged 18 to 60 years

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromodulation Research Clinic, Douglas Mental Health University Institute

Montreal, Quebec, H4H1R3, Canada

Location

Related Publications (5)

  • 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.

    PMID: 18680573BACKGROUND

  • 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.

    PMID: 20105234BACKGROUND

  • 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.

    PMID: 17553993BACKGROUND

  • 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.

    PMID: 20335459BACKGROUND

  • 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.

    PMID: 22347844BACKGROUND

MeSH Terms

Conditions

Impulsive Behavior

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Marcelo Berlim, MD, MSc

    Neuromodulation Research Clinic, Douglas Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuromodulation Research Clinic

Study Record Dates

First Submitted

January 16, 2013

First Posted

March 6, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 6, 2014

Record last verified: 2014-10

Locations

CA(1)