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

NCT ID: NCT04218383

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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Impulsive Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Anode placed over the OFC and cathode placed over the right primary motor cortex.

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.

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Anode placed over the OFC and cathode placed over the right primary motor cortex.

Interventions

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Transcranial Direct Current Stimulation

Anode placed over the OFC and cathode placed over the right primary motor cortex.

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander McGirr, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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REB19-0171

Identifier Type: -

Identifier Source: org_study_id

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