Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03886025
Other study ID # 6025821
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date April 30, 2025

Study information

Verified date April 2024
Source Queen's University
Contact Najat Khalifa, MD, FRCPC
Phone 6135444900
Email nrk2@queensu.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Anodal transcranial Direct Current Stimulation (tDCS)
Non-invasive brain stimulation
Behavioral:
Cognitive training
Iowa Gambling Task will be used for cognitive training
Other:
Sham transcranial Direct Current Stimulation (tDCS)
Non-invasive brain stimulation

Locations

Country Name City State
Canada Queen's University Kingston Ontario

Sponsors (2)

Lead Sponsor Collaborator
Dr. Najat Khalifa University of Nottingham

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Stop Signal Task (SST) reaction time SST is a measure of inhibitory control Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
Secondary Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores 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
Secondary Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score 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
See also
  Status Clinical Trial Phase
Completed NCT01799291 - Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder N/A
Completed NCT03185715 - Oocyte Recipient's Decision in the Number of Embryos to be Transferred N/A
Completed NCT05974943 - The Effect of Problem Solving and Decision Making Training Given to Nurses Managers N/A
Terminated NCT05024903 - A Novel E-health Platform Phase 2/Phase 3
Completed NCT04509063 - Investigating Public Enthusiasm for Mammography Screening in Denmark N/A
Completed NCT03762239 - Effect of Air Pollution on the Cognitive Function of Adolescents N/A
Not yet recruiting NCT06081842 - Strengthening Contraceptive Counseling Services: Research Protocol for a Multi-phase Complex Intervention in Pakistan and Nigeria N/A
Completed NCT01190488 - Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians_Matlock N/A
Active, not recruiting NCT04466865 - A Communication Tool to Assist Older Adults Facing Dialysis Choices N/A
Active, not recruiting NCT06046625 - Needs and Preferences of Patients With Head-neck Cutaneous SCC
Completed NCT03181841 - Effects of PF-06412562 on Value-based Decision-making in Healthy Individuals Phase 1
Recruiting NCT03554694 - Gut-brain Axis, Brain Function, and Behaviour. N/A
Recruiting NCT05201534 - Interventions in Mathematics and Cognitive Skills N/A
Completed NCT04000802 - Evaluation of the Decision-making During Multidisciplinary Meetings for Digestive Cancers
Completed NCT04034979 - Evaluation of a Decision Aid About Life-sustaining Therapies N/A
Active, not recruiting NCT05173922 - "Safety in Dementia": An Online Caregiver Intervention N/A
Withdrawn NCT01098864 - Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting. N/A
Recruiting NCT05364801 - Impact of Anxiety on the Decision-making Processes of Anesthesiologists
Completed NCT06355999 - Levari Exp.20: 2D - Partial Feedback N/A
Enrolling by invitation NCT05390411 - Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial N/A