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

NCT03886025 | Recruiting

• 1 other identifier: 6025821
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impulsivity; Decision Making

Keywords

transcranial Direct Current Stimulation (tDCS); Decision-making; Implusivity; Brain stimulation

Outcome Measures

Primary Outcomes (1)

• Iowa Gambling Task (IGT) net scores

  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 Outcomes (3)

• Stop Signal Task (SST) reaction time

  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

  Baseline

• Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score

  Baseline

Study Arms (2)

Combined anodal tDCS and cognitive training

EXPERIMENTAL

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); Behavioral: Cognitive training

Combined sham tDCS and cognitive training

SHAM COMPARATOR

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; Other: Sham transcranial Direct Current Stimulation (tDCS)

Interventions

Anodal transcranial Direct Current Stimulation (tDCS) OTHER

Non-invasive brain stimulation

Combined anodal tDCS and cognitive training

Cognitive training BEHAVIORAL

Iowa Gambling Task will be used for cognitive training

Combined anodal tDCS and cognitive training; Combined sham tDCS and cognitive training

Sham transcranial Direct Current Stimulation (tDCS) OTHER

Non-invasive brain stimulation

Combined sham tDCS and cognitive training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Consenting volunteers aged between 18 and 40.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Najat Khalifa: lead
• University of Nottingham: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L7X3, Canada

RECRUITING

MeSH Terms

Conditions

Impulsive Behavior

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Najat Khalifa, MD

  Queen's University - Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Najat Khalifa, MD, FRCPC

CONTACT

6135444900; nrk2@queensu.ca

Tariq Hassan, FRCPSC

CONTACT

6135444900; hassant@providencecare.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single blind Randomized Controlled Trial

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 22, 2019
• Study Start: September 15, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)