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

NCT ID: NCT03886025

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Impulsivity Decision Making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blind Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be randomly assigned to receive either combined anodal tDCS and cognitive training or combined sham tDCS and cognitive training. The participants will be blind to whether the tDCS is active or sham.

Study Groups

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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.

Group Type EXPERIMENTAL

Anodal transcranial Direct Current Stimulation (tDCS)

Intervention Type OTHER

Non-invasive brain stimulation

Cognitive training

Intervention Type BEHAVIORAL

Iowa Gambling Task will be used for cognitive training

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.

Group Type SHAM_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

Iowa Gambling Task will be used for cognitive training

Sham transcranial Direct Current Stimulation (tDCS)

Intervention Type OTHER

Non-invasive brain stimulation

Interventions

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Anodal transcranial Direct Current Stimulation (tDCS)

Non-invasive brain stimulation

Intervention Type OTHER

Cognitive training

Iowa Gambling Task will be used for cognitive training

Intervention Type BEHAVIORAL

Sham transcranial Direct Current Stimulation (tDCS)

Non-invasive brain stimulation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role collaborator

Dr. Najat Khalifa

OTHER

Sponsor Role lead

Responsible Party

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Dr. Najat Khalifa

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Najat Khalifa, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University - Canada

Locations

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Queen's University

Kingston, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Najat Khalifa, MD, FRCPC

Role: CONTACT

6135444900

Tariq Hassan, FRCPSC

Role: CONTACT

6135444900

Facility Contacts

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Najat Khalifa, MD, FRCPC

Role: primary

6135444900

Tariq Hassan, FRCPSC

Role: backup

6135444900

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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6025821

Identifier Type: -

Identifier Source: org_study_id

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