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

Impulsive Behavior Clinical Trial

— tDCS  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04218383
• Other study ID #: REB19-0171
• Status: Suspended
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: November 1, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Impulsive Behavior

Intervention

Device:
• Transcranial Direct Current Stimulation
Anode placed over the OFC and cathode placed over the right primary motor cortex.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (15)

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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. Epub 2007 Jun 28. — View Citation

Kringelbach ML. The human orbitofrontal cortex: linking reward to hedonic experience. Nat Rev Neurosci. 2005 Sep;6(9):691-702. Review. — View Citation

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. — View Citation

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. Epub 2006 Dec 21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 May 18. — View Citation

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. Erratum in: Biol Psychiatry. 2003 Sep 1;54(5):585. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cognitive Control	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
Secondary	Food-specific cognitive control	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
Secondary	Delayed discounting	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
Secondary	Motor impulsivity	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.
Secondary	Moderation of effect by self-reported measures of impulsivity and dysregulated eating	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.