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

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ClinicalTrials.gov Identifier: NCT04218383
Recruitment Status : Suspended (Coronavirus pandemic)
First Posted : January 6, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of Calgary

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.

Condition or disease Intervention/treatment Phase
Impulsive Behavior Device: Transcranial Direct Current Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Transcranial Direct Current Stimulation (tDCS) Applied Over the Orbitofrontal Cortex on Impulsivity and Decision Making in Obese Subjects
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : November 1, 2022

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 Name: 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 Name: tDCS




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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)).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218383


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Alexander McGirr, MD, MSc University of Calgary
Publications:

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04218383    
Other Study ID Numbers: REB19-0171
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Impulsive Behavior