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Transcranial Direct Current Stimulation for Impulsivity and Food-related Impulsivity in Obesity (tDCS)

Primary Purpose

Impulsive Behavior

Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Impulsive Behavior

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men or Women aged 18 to 65
  • have body mass index of 35 or above
  • have had no recent change in medications in the 2 weeks prior participating in the study
  • able to fast for 4 hours prior participating in the study

Exclusion Criteria:

  • Active Substance use disorder
  • Active Suicidal ideation
  • Psychoactive Medication
  • Past or current Gambling disorder
  • Past or current Anorexia
  • Past or current Bulimia Nervosa
  • Past or current Psychosis
  • Visual impairments preventing performance of the neuropsychological tasks
  • Epilepsy
  • Traumatic Brain Injury
  • Stroke
  • Neurological disorder affecting motor functions (Parkinsons, Huntington's, etc)
  • Previous participation in tDCS research/treatment

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Experimental: Active Left OFC Group

Sham Comparator: Sham left OFC Group

Arm Description

2mA will be applied for 20 minutes with the tDCS anode applied to the left OFC and Cathode applied to the right primary motor cortex.

Current will be ramped up for 30s followed by a 30s ramp down to mimic the physical sensation of stimulation and habituation. The anode placed over the left OFC and cathode placed over the right primary motor cortex.

Outcomes

Primary Outcome Measures

Probabilistic Decision Making
Net score of the Iowa Gambling Task The net score ranges from -20 to 30. Higher values represent a better outcome (i.e., enhanced decision-making)

Secondary Outcome Measures

Cognitive Control
Interference index in the Stroop Color-word Task. Interference index is the reaction time computed between the presentation of the stimulus and the response of the participant. It typically ranges from 0 to 300 millisecond, with smaller values of reaction time indicate better outcome (i.e., better cognitive control).
Food-specific cognitive control
The interference index in the Food-Stroop Color-Word test. Interference index is the reaction time computed between the presentation of the stimulus and the response of the participant. It typically ranges from 0 to 300 millisecond, with smaller values of reaction time indicate better outcome (i.e., better Food-specific cognitive control).
Delayed discounting
The discount rate for delayed monetary rewards. This rate is quantified by the hyperbolic discounting function using the following equation: V = A/(1+kD), where A presents the value of the delayed reward A at delay D, and k is a free parameter that determines the discount rate, with higher values of k indicate worse outcome (i.e., greater discounting of rewards as a function of time).
Motor impulsivity
The stop-signal reaction time in the Stop-Signal Task. The stop signal reaction time ranges from 50 to 250, where greater values represent worse outcome (i.e, increased motor impulsivity).
Moderation of effect by self-reported measures of impulsivity and dysregulated eating
Individuals with high levels of impulsivity, impulsive eating, binge eating, self-reported food addiction will show greater moderation by tDCS on our primary and secondary outcomes. Barrat's impulsiveness scale-11 with a range of scores from 0 to 120, with higher scores indicating greater impulsivity. Reward-based eating drive scale-13 with a range of scores from 0 to 54, with higher scores indicating greater uncontrolled eating. Binge eating scale with a range of scores from 0 to 46: minimal binge eating ( >17), moderate binge eating (18-26), and severe binge eating (<27)). Yale Food Addiction Scale with a range of symptom severity from 0 to 7: mild (2-3 symptoms), moderate (4-5 symptoms), severe (6 or more symptoms)).

Full Information

First Posted
January 2, 2020
Last Updated
January 13, 2021
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04218383
Brief Title
Transcranial Direct Current Stimulation for Impulsivity and Food-related Impulsivity in Obesity
Acronym
tDCS
Official Title
Effect of Transcranial Direct Current Stimulation (tDCS) Applied Over the Orbitofrontal Cortex on Impulsivity and Decision Making in Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Suspended
Why Stopped
Coronavirus pandemic
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate impulsivity in obese participants.
Detailed Description
In this single-blind, sham controlled study, the investigators will assess whether transcranial direct current stimulation (tDCS; a safe non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate impulsivity in obese volunteers. The investigators hypothesize that tDCS applied to the OFC, in comparison to sham tDCS, will significantly reduce impulsivity and enhance decision making as measured by computerized neurocognitive tasks. For this study the investigators will enroll 30 obese individuals aged 18-65 years. Participants will be assessed with a battery of computerized tasks as well as self-reported questionnaires on eating, impulsivity, mood and anxiety. Assessments will be carried out before, during, and after a single 20-minute 2mA tDCS session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Active Left OFC Group
Arm Type
Active Comparator
Arm Description
2mA will be applied for 20 minutes with the tDCS anode applied to the left OFC and Cathode applied to the right primary motor cortex.
Arm Title
Sham Comparator: Sham left OFC Group
Arm Type
Sham Comparator
Arm Description
Current will be ramped up for 30s followed by a 30s ramp down to mimic the physical sensation of stimulation and habituation. The anode placed over the left OFC and cathode placed over the right primary motor cortex.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Anode placed over the OFC and cathode placed over the right primary motor cortex.
Primary Outcome Measure Information:
Title
Probabilistic Decision Making
Description
Net score of the Iowa Gambling Task The net score ranges from -20 to 30. Higher values represent a better outcome (i.e., enhanced decision-making)
Time Frame
Before and after a 20-minute tDCS session
Secondary Outcome Measure Information:
Title
Cognitive Control
Description
Interference index in the Stroop Color-word Task. Interference index is the reaction time computed between the presentation of the stimulus and the response of the participant. It typically ranges from 0 to 300 millisecond, with smaller values of reaction time indicate better outcome (i.e., better cognitive control).
Time Frame
Before and after a 20-minute tDCS session
Title
Food-specific cognitive control
Description
The interference index in the Food-Stroop Color-Word test. Interference index is the reaction time computed between the presentation of the stimulus and the response of the participant. It typically ranges from 0 to 300 millisecond, with smaller values of reaction time indicate better outcome (i.e., better Food-specific cognitive control).
Time Frame
Before and after a 20-minute tDCS session
Title
Delayed discounting
Description
The discount rate for delayed monetary rewards. This rate is quantified by the hyperbolic discounting function using the following equation: V = A/(1+kD), where A presents the value of the delayed reward A at delay D, and k is a free parameter that determines the discount rate, with higher values of k indicate worse outcome (i.e., greater discounting of rewards as a function of time).
Time Frame
Before and after a 20-minute tDCS session
Title
Motor impulsivity
Description
The stop-signal reaction time in the Stop-Signal Task. The stop signal reaction time ranges from 50 to 250, where greater values represent worse outcome (i.e, increased motor impulsivity).
Time Frame
Before and after a 20-minute tDCS session.
Title
Moderation of effect by self-reported measures of impulsivity and dysregulated eating
Description
Individuals with high levels of impulsivity, impulsive eating, binge eating, self-reported food addiction will show greater moderation by tDCS on our primary and secondary outcomes. Barrat's impulsiveness scale-11 with a range of scores from 0 to 120, with higher scores indicating greater impulsivity. Reward-based eating drive scale-13 with a range of scores from 0 to 54, with higher scores indicating greater uncontrolled eating. Binge eating scale with a range of scores from 0 to 46: minimal binge eating ( >17), moderate binge eating (18-26), and severe binge eating (<27)). Yale Food Addiction Scale with a range of symptom severity from 0 to 7: mild (2-3 symptoms), moderate (4-5 symptoms), severe (6 or more symptoms)).
Time Frame
Before and after a 20-minute tDCS session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men or Women aged 18 to 65 have body mass index of 35 or above have had no recent change in medications in the 2 weeks prior participating in the study able to fast for 4 hours prior participating in the study Exclusion Criteria: Active Substance use disorder Active Suicidal ideation Psychoactive Medication Past or current Gambling disorder Past or current Anorexia Past or current Bulimia Nervosa Past or current Psychosis Visual impairments preventing performance of the neuropsychological tasks Epilepsy Traumatic Brain Injury Stroke Neurological disorder affecting motor functions (Parkinsons, Huntington's, etc) Previous participation in tDCS research/treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander McGirr, MD, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Transcranial Direct Current Stimulation for Impulsivity and Food-related Impulsivity in Obesity

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