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

January 13, 2021 updated by: University of Calgary

Effect of Transcranial Direct Current Stimulation (tDCS) Applied Over the Orbitofrontal Cortex on Impulsivity and Decision Making in Obese Subjects

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Experimental: Active Left OFC Group
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.
Device: Transcranial Direct Current Stimulation
Anode placed over the OFC and cathode placed over the right primary motor cortex.
Other Names:
  • tDCS
SHAM_COMPARATOR: Sham Comparator: Sham left OFC Group
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.
Device: Transcranial Direct Current Stimulation
Anode placed over the OFC and cathode placed over the right primary motor cortex.
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probabilistic Decision Making
Time Frame: Before and after a 20-minute tDCS session
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)
Before and after a 20-minute tDCS session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Control
Time Frame: Before and after a 20-minute tDCS session
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).
Before and after a 20-minute tDCS session
Food-specific cognitive control
Time Frame: Before and after a 20-minute tDCS session
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).
Before and after a 20-minute tDCS session
Delayed discounting
Time Frame: Before and after a 20-minute tDCS session
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).
Before and after a 20-minute tDCS session
Motor impulsivity
Time Frame: Before and after a 20-minute tDCS session.
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).
Before and after a 20-minute tDCS session.
Moderation of effect by self-reported measures of impulsivity and dysregulated eating
Time Frame: Before and after a 20-minute tDCS session.
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)).
Before and after a 20-minute tDCS session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Alexander McGirr, MD, MSc, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 3, 2020

Primary Completion (ANTICIPATED)

April 30, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (ACTUAL)

January 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB19-0171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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