Clinical trial NCT04218383: Transcranial Direct Current Stimulation for Impulsivity and Food-related Impulsivity in Obesity
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
Overall status: SUSPENDED
Phase: NA
Conditions: Impulsive Behavior
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Probabilistic Decision Making
timeFrame: Before and after a 20-minute tDCS session
Secondary outcomes:
measure: Cognitive Control
timeFrame: Before and after a 20-minute tDCS session
measure: Food-specific cognitive control
timeFrame: Before and after a 20-minute tDCS session
measure: Delayed discounting
timeFrame: Before and after a 20-minute tDCS session
measure: Motor impulsivity
timeFrame: Before and after a 20-minute tDCS session.
measure: Moderation of effect by self-reported measures of impulsivity and dysregulated eating
timeFrame: Before and after a 20-minute tDCS session.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Alexander McGirr, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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