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

Primary Purpose

Impulsivity, Decision Making

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anodal transcranial Direct Current Stimulation (tDCS)
Cognitive training
Sham transcranial Direct Current Stimulation (tDCS)
Sponsored by
Dr. Najat Khalifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impulsivity focused on measuring transcranial Direct Current Stimulation (tDCS), Decision-making, Implusivity, Brain stimulation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Queen's UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Combined anodal tDCS and cognitive training

Combined sham tDCS and cognitive training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Iowa Gambling Task (IGT) net scores
IGT is a measure of decision making under conditions of uncertainty and risk.

Secondary Outcome Measures

Stop Signal Task (SST) reaction time
SST is a measure of inhibitory control
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.
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.

Full Information

First Posted
March 15, 2019
Last Updated
March 27, 2023
Sponsor
Dr. Najat Khalifa
Collaborators
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT03886025
Brief Title
Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training and Decision-making
Acronym
tDCS-CTDM
Official Title
The Use of Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Modulate Decision-making in Healthy People
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Najat Khalifa
Collaborators
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsivity, Decision Making
Keywords
transcranial Direct Current Stimulation (tDCS), Decision-making, Implusivity, Brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind Randomized Controlled Trial
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined anodal tDCS and cognitive training
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined sham tDCS and cognitive training
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Anodal transcranial Direct Current Stimulation (tDCS)
Intervention Description
Non-invasive brain stimulation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
Iowa Gambling Task will be used for cognitive training
Intervention Type
Other
Intervention Name(s)
Sham transcranial Direct Current Stimulation (tDCS)
Intervention Description
Non-invasive brain stimulation
Primary Outcome Measure Information:
Title
Iowa Gambling Task (IGT) net scores
Description
IGT is a measure of decision making under conditions of uncertainty and risk.
Time Frame
Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
Secondary Outcome Measure Information:
Title
Stop Signal Task (SST) reaction time
Description
SST is a measure of inhibitory control
Time Frame
Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation
Title
Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores
Description
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.
Time Frame
Baseline
Title
Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Najat Khalifa, MD, FRCPC
Phone
6135444900
Email
nrk2@queensu.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tariq Hassan, FRCPSC
Phone
6135444900
Email
hassant@providencecare.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najat Khalifa, MD
Organizational Affiliation
Queen's University - Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L7X3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najat Khalifa, MD, FRCPC
Phone
6135444900
Email
nrk2@queensu.ca
First Name & Middle Initial & Last Name & Degree
Tariq Hassan, FRCPSC
Phone
6135444900
Email
hassant@providencecare.ca
First Name & Middle Initial & Last Name & Degree
Najat Khalifa, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Tariq Hassan, FRCPSC
First Name & Middle Initial & Last Name & Degree
Peter Liddle, PhD
First Name & Middle Initial & Last Name & Degree
Katy Jones, PhD
First Name & Middle Initial & Last Name & Degree
Roumen Milev, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No participant data will be shared with researchers other than the study investigators.

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

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