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Impulsive BehaviorNCT01805401

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

A study testing Transcranial Direct Current Stimulation in people with Impulsive Behavior and Suicidal Impulses, run by Douglas Mental Health University Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Impulsive Behavior, Suicidal Impulses
What is being tested?
Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteCanada
Study dates
Jan 2013to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Men or women aged 18 to 60 years

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Neuromodulation Research Clinic, Douglas Mental Health University Institute

    Montreal, Quebec, H4H1R3

Other trials in Canada

About this study

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

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.

Read the 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.

Keywords
Decision-making, Impulse control, Transcranial direct current stimulation, Brain stimulation, Neuromodulation, tDCS, Iowa Gambling Task, Stroop Word-Color Task
Medical subject headings
Impulsive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01805401
Study groupRoleWhat they receive
Left OFC GroupExperimentalAnode applied to the left OFC and cathode applied to the right OFC
Receives: Device: Transcranial Direct Current Stimulation
Right OFC GroupExperimentalAnode applied to the right OFC and cathode applied to the left OFC
Receives: Device: Transcranial Direct Current Stimulation
Sham tDCSSham comparatorNot described
Receives: Device: Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Before and after a 30-minute tDCS session

Secondary outcomes (5)

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

    Measured: Before and after a 30-minute tDCS session

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

    Measured: Before and after a 30-minute tDCS session

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

    Measured: Before and after a 30-minute tDCS session

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

    Measured: Before and after a 30-minute tDCS session

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

    Measured: Before and after a 30-minute tDCS session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01805401
Sponsor's protocol ID
REB-11/42
Other IDs
2012 YIA
Status last verified
Oct 2014
First submitted
16 Jan 2013
Last updated
6 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18680573

  • 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.

    PubMed 20105234

  • 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.

    PubMed 17553993

  • 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.

    PubMed 20335459

  • 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.

    PubMed 22347844

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation in people with Impulsive Behavior and Suicidal Impulses, run by Douglas Mental Health University Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the net score of the Iowa Gambling Task (time frame: Before and after a 30-minute tDCS session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01805401, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014.

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