Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training and Decision-making (tDCS-CTDM)

April 1, 2024 updated by: Dr. Najat Khalifa

The Use of Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Modulate Decision-making in Healthy People

This study aims to (i) assess the effects of combined tDCS and cognitive training on decision-making on a trained task (Iowa Gambling Task; IGT); and (ii) test generalization to a closely related cognitive domain, namely motor impulsivity. It is hypothesized that combined anodal tDCS and cognitive training will result in more advantageous decisions and better impulse control than combined sham tDCS and cognitive training.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Impaired decision-making under conditions of uncertainty and risk has been implicated in maladaptive personality development and violent behaviour. There is a dearth of studies that examined the effects of combined tDCS and cognitive training on decision-making under conditions of uncertainty and risk. It is also unclear if these effects are generalizable to tasks in other domains such as response inhibition (motor impulsivity).

To examine these issues further, a single blind parallel arms randomized controlled trial will be conducted, involving a sample of healthy volunteers aged between 18 and 40. This will entail applying either active or sham tDCS over the anterior frontal cortex (including the vm-PFC) while participants undertake decision-making training using the Iowa Gambling Task. Decision-making will be assessed using the IGT, which is a computerized gambling task used to assess decision-making under conditions of uncertainty and risk. IGT is sensitive to damage to the ventromedial prefrontal cortex (vmPFC), which is considered to play a key role in decision-making. Motor impulsivity will be measured using the Stop Signal Task (SST). The UPPS+P Impulsive Behaviour Scale will be used to index trait impulsivity. The Profile of Mood States will be used to measure state emotion before and after tDCS.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Najat Khalifa, MD, FRCPC
  • Phone Number: 6135444900
  • Email: nrk2@queensu.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L7X3
        • Recruiting
        • Queen's University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Najat Khalifa, MD, FRCPC
        • Sub-Investigator:
          • Tariq Hassan, FRCPSC
        • Sub-Investigator:
          • Peter Liddle, PhD
        • Sub-Investigator:
          • Katy Jones, PhD
        • Sub-Investigator:
          • Roumen Milev, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Consenting volunteers aged between 18 and 40.

Exclusion Criteria:

  • Individuals with epilepsy, other neurological conditions and history of significant head injury will be excluded.
  • Individuals with a history of substance misuse, major mental disorder and those receiving psychotropic medication will be also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined anodal tDCS and cognitive training
Combined anodal tDCS and cognitive training. Anodal tDCS will be delivered while the participant is completing the cognitive training task (Iowa Gambling Task). Anodal tDCS will use a constant current of 2mA, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively. The duration of each tDCS session will be 20 minutes.
Other: Anodal transcranial Direct Current Stimulation (tDCS)
Non-invasive brain stimulation
Behavioral: Cognitive training
Iowa Gambling Task will be used for cognitive training
Sham Comparator: Combined sham tDCS and cognitive training
Combined sham tDCS and cognitive training. Sham tDCS will be delivered while the participant is completing the cognitive training task (Iowa Gambling Task). For sham tDCS, the current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The duration of each tDCS session will be 20 minutes.
Behavioral: Cognitive training
Iowa Gambling Task will be used for cognitive training
Other: Sham transcranial Direct Current Stimulation (tDCS)
Non-invasive brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iowa Gambling Task (IGT) net scores
Time Frame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
IGT is a measure of decision making under conditions of uncertainty and risk.
Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stop Signal Task (SST) reaction time
Time Frame: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
SST is a measure of inhibitory control
Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores
Time Frame: Baseline
UPPS+P is a 59 item self-report measure of trait impulsivity. Each item is rated on a scale of 1-4 (1= totally disagree, 4=totally agree) yielding a total score out of 216 (range=59 - 216) Higher scores denote higher impulsivity.
Baseline
Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score
Time Frame: Baseline
Abbreviated POMS is a 40-item measure of current mood states. Each item is rated on a scale of 0-4 (0=Not at all, 4=Extremely). The total Mood Disturbance score is calculated by summing the totals for the negative subscales (tension, depression, anger, fatigue, confusion) and then subtracting the totals for the positive subscales (vigour, esteem related affect) and then adding a constant 100. Higher scores denote greater mood disturbance.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Najat Khalifa

Collaborators

University of Nottingham

Investigators

  • Principal Investigator: Najat Khalifa, MD, Queen's University - Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6025821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No participant data will be shared with researchers other than the study investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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