NCT04218383

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

January 2, 2020

Last Update Submit

January 13, 2021

Conditions

Impulsive Behavior

Outcome Measures

Primary Outcomes (1)

  • 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)

    Before and after a 20-minute tDCS session

Secondary Outcomes (5)

  • Cognitive Control

    Before and after a 20-minute tDCS session

  • Food-specific cognitive control

    Before and after a 20-minute tDCS session

  • Delayed discounting

    Before and after a 20-minute tDCS session

  • Motor impulsivity

    Before and after a 20-minute tDCS session.

  • Moderation of effect by self-reported measures of impulsivity and dysregulated eating

    Before and after a 20-minute tDCS session.

Study Arms (2)

Experimental: Active Left OFC Group

ACTIVE COMPARATOR

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

Sham Comparator: Sham left OFC Group

SHAM COMPARATOR

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

Interventions

Transcranial Direct Current StimulationDEVICE

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

Also known as: tDCS
Experimental: Active Left OFC GroupSham Comparator: Sham left OFC Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (15)

  • Bechara A, Damasio AR, Damasio H, Anderson SW. Insensitivity to future consequences following damage to human prefrontal cortex. Cognition. 1994 Apr-Jun;50(1-3):7-15. doi: 10.1016/0010-0277(94)90018-3.

    PMID: 8039375BACKGROUND

  • Kringelbach ML. The human orbitofrontal cortex: linking reward to hedonic experience. Nat Rev Neurosci. 2005 Sep;6(9):691-702. doi: 10.1038/nrn1747.

    PMID: 16136173BACKGROUND

  • Mason AE, Vainik U, Acree M, Tomiyama AJ, Dagher A, Epel ES, Hecht FM. Improving Assessment of the Spectrum of Reward-Related Eating: The RED-13. Front Psychol. 2017 May 30;8:795. doi: 10.3389/fpsyg.2017.00795. eCollection 2017.

    PMID: 28611698BACKGROUND

  • Finlayson G, King N, Blundell J. The role of implicit wanting in relation to explicit liking and wanting for food: implications for appetite control. Appetite. 2008 Jan;50(1):120-7. doi: 10.1016/j.appet.2007.06.007. Epub 2007 Jun 28.

    PMID: 17655972BACKGROUND

  • Nijs IM, Franken IH, Muris P. The modified Trait and State Food-Cravings Questionnaires: development and validation of a general index of food craving. Appetite. 2007 Jul;49(1):38-46. doi: 10.1016/j.appet.2006.11.001. Epub 2006 Dec 21.

    PMID: 17187897BACKGROUND

  • O'Doherty JP, Deichmann R, Critchley HD, Dolan RJ. Neural responses during anticipation of a primary taste reward. Neuron. 2002 Feb 28;33(5):815-26. doi: 10.1016/s0896-6273(02)00603-7.

    PMID: 11879657BACKGROUND

  • Ouellet J, McGirr A, Van den Eynde F, Jollant F, Lepage M, Berlim MT. Enhancing decision-making and cognitive impulse control with transcranial direct current stimulation (tDCS) applied over the orbitofrontal cortex (OFC): A randomized and sham-controlled exploratory study. J Psychiatr Res. 2015 Oct;69:27-34. doi: 10.1016/j.jpsychires.2015.07.018. Epub 2015 Jul 17.

    PMID: 26343591BACKGROUND

  • Phelan S, Hassenstab J, McCaffery JM, Sweet L, Raynor HA, Cohen RA, Wing RR. Cognitive interference from food cues in weight loss maintainers, normal weight, and obese individuals. Obesity (Silver Spring). 2011 Jan;19(1):69-73. doi: 10.1038/oby.2010.138. Epub 2010 Jun 10.

    PMID: 20539296BACKGROUND

  • Pursey KM, Stanwell P, Callister RJ, Brain K, Collins CE, Burrows TL. Neural responses to visual food cues according to weight status: a systematic review of functional magnetic resonance imaging studies. Front Nutr. 2014 Jul 9;1:7. doi: 10.3389/fnut.2014.00007. eCollection 2014.

    PMID: 25988110BACKGROUND

  • Ray MK, Sylvester MD, Osborn L, Helms J, Turan B, Burgess EE, Boggiano MM. The critical role of cognitive-based trait differences in transcranial direct current stimulation (tDCS) suppression of food craving and eating in frank obesity. Appetite. 2017 Sep 1;116:568-574. doi: 10.1016/j.appet.2017.05.046. Epub 2017 May 29.

    PMID: 28572072BACKGROUND

  • Rothemund Y, Preuschhof C, Bohner G, Bauknecht HC, Klingebiel R, Flor H, Klapp BF. Differential activation of the dorsal striatum by high-calorie visual food stimuli in obese individuals. Neuroimage. 2007 Aug 15;37(2):410-21. doi: 10.1016/j.neuroimage.2007.05.008. Epub 2007 May 18.

    PMID: 17566768BACKGROUND

  • Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.

    PMID: 12946886BACKGROUND

  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PMID: 9881538BACKGROUND

  • Swinburn B, Sacks G, Ravussin E. Increased food energy supply is more than sufficient to explain the US epidemic of obesity. Am J Clin Nutr. 2009 Dec;90(6):1453-6. doi: 10.3945/ajcn.2009.28595. Epub 2009 Oct 14.

    PMID: 19828708BACKGROUND

  • van der Laan LN, de Ridder DT, Viergever MA, Smeets PA. The first taste is always with the eyes: a meta-analysis on the neural correlates of processing visual food cues. Neuroimage. 2011 Mar 1;55(1):296-303. doi: 10.1016/j.neuroimage.2010.11.055. Epub 2010 Nov 25.

    PMID: 21111829BACKGROUND

MeSH Terms

Conditions

Impulsive Behavior

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Alexander McGirr, MD, MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 6, 2020

Study Start

February 3, 2020

Primary Completion

April 30, 2022

Study Completion

November 1, 2022

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)