Impulsive BehaviortDCSNCT04218383

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

A study testing Transcranial Direct Current Stimulation in people with Impulsive Behavior, run by University of Calgary at 1 site in Canada.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Impulsive Behavior
What is being tested?: Transcranial Direct Current Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteCanada
Study dates: 3 Feb 2020to 1 Nov 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Active Substance use disorder
Active Suicidal ideation
Psychoactive Medication
Past or current Gambling disorder
Past or current Anorexia
Past or current Bulimia Nervosa

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Calgary
Calgary, Alberta, T2N 1N4

Other trials in Canada

About this study

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

Read the 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.

Conditions: Impulsive Behavior
Being tested: Transcranial Direct Current Stimulation
Medical subject headings: Impulsive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Direct Current StimulationDevice
Also called tDCS
Anode placed over the OFC and cathode placed over the right primary motor cortex.

Study groups in NCT04218383
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Before and after a 20-minute tDCS session

Secondary outcomes (5)

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).
Measured: Before and after a 20-minute tDCS session
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).
Measured: Before and after a 20-minute tDCS session
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).
Measured: Before and after a 20-minute tDCS session
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).
Measured: Before and after a 20-minute tDCS session.
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)).
Measured: Before and after a 20-minute tDCS session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 20201 Nov 2022

First posted6 Jan 2020
Study start3 Feb 2020
Primary completion30 Apr 2022 (estimated)
Study completion1 Nov 2022 (estimated)

Why it stopped: Coronavirus pandemic

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Impulsive BehaviorStudies of the same condition, open and under way.
More trials run by University of CalgaryThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04218383
Sponsor's protocol ID: REB19-0171
Acronym: tDCS
Status last verified: Jan 2021
First submitted: 2 Jan 2020
Last updated: 15 Jan 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 8039375
Kringelbach ML. The human orbitofrontal cortex: linking reward to hedonic experience. Nat Rev Neurosci. 2005 Sep;6(9):691-702. doi: 10.1038/nrn1747.
PubMed 16136173
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.
PubMed 28611698
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.
PubMed 17655972
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.
PubMed 17187897
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.
PubMed 11879657
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.
PubMed 26343591
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.
PubMed 20539296
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.
PubMed 25988110
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.
PubMed 28572072
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.
PubMed 17566768
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.
PubMed 12946886
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.
PubMed 9881538
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.
PubMed 19828708
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.
PubMed 21111829

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Recruiting
Trial of Social Work Services in Fracture Clinic Setting
Orthopaedic Fractures, Socioeconomic Factors
RecruitingObservational study
The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
Mechanical Neck Pain, Forward Head Posture (FHP)
Active, not recruiting
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Chronic Pain, Opioid Use Disorder

All Impulsive Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Transcranial Direct Current Stimulation (tDCS) Applied Over the Orbitofrontal Cortex on Impulsivity and Decision Making in Obese Subjects
ClinicalTrials.gov ID: NCT04218383
Acronym / sponsor ID: tDCS / REB19-0171
Conditions: Impulsive Behavior
Study type: Interventional
Recruitment status: SuspendedReason stopped: Coronavirus pandemic
Enrolment: 30 participants (estimated)
Lead sponsor: University of CalgaryUniversity, hospital or other
Study start: 3 Feb 2020 (actual)
Primary completion: 30 Apr 2022 (estimated)
Study completion: 1 Nov 2022 (estimated)
First posted: 6 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Experimental: Active Left OFC Group	Active comparator	Device: Transcranial Direct Current Stimulation2mA will be applied for 20 minutes with the tDCS anode applied to the left OFC and Cathode applied to the right primary motor cortex.
Sham Comparator: Sham left OFC Group	Sham comparator	Device: Transcranial Direct Current StimulationCurrent 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

Active Substance use disorder
Active Suicidal ideation
Psychoactive Medication
Past or current Gambling disorder
Past or current Anorexia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Direct Current StimulationAlso: tDCSAnode placed over the OFC and cathode placed over the right primary motor cortex.	Device	Experimental: Active Left OFC Group, Sham Comparator: Sham left OFC Group

Primary outcome

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)

5 secondary outcomes

Cognitive Control
Time frame: Before and after a 20-minute tDCS session
Food-specific cognitive control
Time frame: Before and after a 20-minute tDCS session
Delayed discounting
Time frame: Before and after a 20-minute tDCS session
Motor impulsivity
Time frame: Before and after a 20-minute tDCS session.
Moderation of effect by self-reported measures of impulsivity and dysregulated eating
Time frame: Before and after a 20-minute tDCS session.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
Background: PubMed 8039375Bechara 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.
Background: PubMed 16136173Kringelbach ML. The human orbitofrontal cortex: linking reward to hedonic experience. Nat Rev Neurosci. 2005 Sep;6(9):691-702. doi: 10.1038/nrn1747.
Background: PubMed 28611698Mason 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.
Background: PubMed 17655972Finlayson 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.
Background: PubMed 17187897Nijs 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.
Background: PubMed 11879657O'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.
Background: PubMed 26343591Ouellet 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.
Background: PubMed 20539296Phelan 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.
Background: PubMed 25988110Pursey 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.
Background: PubMed 28572072Ray 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.
Background: PubMed 17566768Rothemund 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.
Background: PubMed 12946886Rush 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.
Individual participant dataSharing planned: No

Related trials for Impulsive Behavior

Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Recruiting
Trial of Social Work Services in Fracture Clinic Setting
Orthopaedic Fractures, Socioeconomic Factors
RecruitingObservational study
The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
Mechanical Neck Pain, Forward Head Posture (FHP)
Active, not recruiting
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Chronic Pain, Opioid Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander McGirr, MD, MSc principal investigator

University of Calgary

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation in people with Impulsive Behavior, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probabilistic Decision Making (time frame: Before and after a 20-minute tDCS session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04218383, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.