ClinicalTrials.gg
CompletedNCT05607121EMPAC-BDDUpdated Mar 18, 2026

TMS Visual Modulation in Body Dysmorphic Disorder

An interventional study of intermittent theta burst stimulation and continuous theta burst stimulation in Body Dysmorphic Disorders, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The goal of this observational study is to test the effects of a type of noninvasive brain stimulation called transcranial magnetic stimulation (TMS) on visual processing in adults with body dysmorphic disorder symptoms when combined with modifying visual attention.

The main goals are to understand, in people with body dysmorphic disorder and people with subclinical body dysmorphic disorder:

  • The effects of intermittent and continuous TMS stimulation of parietal brain regions when done right before visual attention modulation on brain functional connections.
  • The effects of intermittent and continuous TMS stimulation of parietal brain regions when done right before visual attention modulation on global/holistic visual perception.

Participants will receive one type of TMS (intermittent or continuous) followed immediately by an fMRI brain scan during which they will view images of their faces. On the second day, they will do the same, but receive either the intermittent or continuous TMS stimulation that they did not receive on the first day.

Read the detailed description

PROJECT SUMMARY

Individuals with body dysmorphic disorder (BDD) misperceive aspects of their appearance to be conspicuously flawed or defective, despite these being unnoticeable or appearing miniscule to others. With convictions of disfigurement and ugliness, they typically have poor insight or delusional beliefs, obsessive thoughts and compulsive behaviors, anxiety, and depression. These result in significant difficulties in functioning, depression, suicide attempts (25%), and psychiatric hospitalization (50%). Despite this, relatively few studies of the neurobiology, and few treatment studies, have been conducted. This underscores a critical need for research to identify novel targets for intervention based on a comprehensive understanding of the pathophysiological mechanisms. Previous research has uncovered mechanisms that may contribute to perceptual distortions, including prominent abnormalities in visual processing systems. These have contributed to a model of diminished global/holistic processing and enhanced local/detailed processing, attributed to "bottom-up" and "top-down" disturbances in perception. Previous experiments using psychophysical tests, novel behavioral visual modulation techniques, and functional magnetic resonance imaging (fMRI) have probed the brain's visual systems responsible for global and local processing and found early evidence that they may be modifiable in BDD. This study will test if further modification could be achieved using noninvasive neuromodulation with repetitive transcranial magnetic stimulation (TMS). Such modulation may be necessary to enhance the effects of behavioral modulation and induce the magnitude of functional changes necessary to achieve clinically meaningful improvements in perceptual experiences in those with BDD. The proposed experiment will determine whether intermittent and continuous TMS enhances and inhibits, respectively, the effects of a behavioral visual modulation strategy on brain connectivity and on global visual processing on a psychophysical task. This will be tested in individuals with clinical BDD and in individuals with subclinical BDD. Results will contribute to a comprehensive mechanistic model of abnormal visual information processing underlying the core symptom domain of misperceptions of appearance. Further, results will be critical for the development and optimization of future combinations of neuromodulation and novel perceptual retraining treatments.

02

Conditions studied

  • Body Dysmorphic Disorders

Keywords

  • transcranial magnetic stimulation
  • visual processing
  • brain connectivity
  • theta burst stimulation
  • fMRI
03

In context

Body Dysmorphic Disorders

56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.

This study's enrollment of 40 is below the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.

Browse Body Dysmorphic Disorders studies →

Lead sponsor

Centre for Addiction and Mental Health is the lead sponsor of 339 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Body dysmorphic disorder:

Inclusion:

  • males or females
  • ages 18-40
  • meet Diagnostic and Statistical Manual () criteria for Body Dysmorphic Disorder
  • have a Body Dysmorphic Disorder version of the Yale-Brown Obsessive-Compulsive Disorder Scale (BDD-YBOCS) score of ≥20
  • primary appearance concerns of the face or head area
  • medication naïve or medication free for at least 8 weeks prior to enrollment

Subclinical body dysmorphic disorder:

  • males or females
  • ages 18-40
  • have a score on the Dysmorphic Concern Questionnaire of ≥8 (1 standard deviation [STD] above population norms)
  • primary appearance concerns of the face or head area
  • medication naïve or medication free for at least 8 weeks prior to enrollment

Exclusion Criteria:

Body dysmorphic disorder:

  • concurrent major Axis I disorders including substance use disorders, aside from anxiety disorders or depressive disorders as these comorbidities are very common and the sample would otherwise be non-representative; however, BDD must be the primary diagnosis.
  • lifetime: bipolar disorder or psychotic disorder
  • psychotropic medications, aside from a short half-life sedative/hypnotic for insomnia, or a short half-life benzodiazepine as needed for anxiety but not exceeding a frequency of 3 doses in one week and not to be taken on the days of the training or MRI scan
  • current cognitive-behavioral therapy

Subclinical body dysmorphic disorder:

Exclusion:

  • meet full DSM-5 criteria for body dysmorphic disorder
  • current Axis I disorders including substance use disorders
  • lifetime: bipolar disorder or psychotic disorder
  • psychotropic medications, aside from a short half-life sedative/hypnotic for insomnia, or a short half-life benzodiazepine as needed for anxiety but not exceeding a frequency of 3 doses in one week and not to be taken on the days of the training or MRI scan
  • current cognitive-behavioral therapy

Exclusion criteria for all participants:

  • Neurological disorder
  • Pregnancy
  • Current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders
  • Current risk of suicide with a plan and intent
  • Ferromagnetic metal implantations or devices (electronic implants or devices, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates)
  • Visual acuity worse than 20/35 for each eye as determined by Snellen close vision acuity chart (vision will be tested with corrective lenses if participant uses them).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    iTBS then cTBS

    iTBS day 1, cTBS day 2

    Device: intermittent theta burst stimulation · Device: continuous theta burst stimulation

  • Experimental
    cTBS then iTBS

    cTBS day 1, iTBS day 2

    Device: intermittent theta burst stimulation · Device: continuous theta burst stimulation

Interventions

  • Deviceintermittent theta burst stimulation

    transcranial magnetic stimulation

  • Devicecontinuous theta burst stimulation

    transcranial magnetic stimulation

06

What researchers measure

Primary outcomes

  1. Face inversion effect

    In a force-choice recognition task, participants will view sets of upright target faces followed by 2 upright selection faces, and sets of inverted target faces followed by 2 inverted selection faces. They will be instructed to select one of the two faces that is the same as the target face, as quickly and as accurately as possible. The dependent variable is the difference in response times for upright vs. inverted faces.

    Time frame: Before TMS on Day 2

  2. Face inversion effect

    In a force-choice recognition task, participants will view sets of upright target faces followed by 2 upright selection faces, and sets of inverted target faces followed by 2 inverted selection faces. They will be instructed to select one of the two faces that is the same as the target face, as quickly and as accurately as possible. The dependent variable is the difference in response times for upright vs. inverted faces.

    Time frame: After fMRI on Day 2

  3. Face inversion effect

    In a force-choice recognition task, participants will view sets of upright target faces followed by 2 upright selection faces, and sets of inverted target faces followed by 2 inverted selection faces. They will be instructed to select one of the two faces that is the same as the target face, as quickly and as accurately as possible. The dependent variable is the difference in response times for upright vs. inverted faces.

    Time frame: Before TMS on Day 3

  4. Face inversion effect

    In a force-choice recognition task, participants will view sets of upright target faces followed by 2 upright selection faces, and sets of inverted target faces followed by 2 inverted selection faces. They will be instructed to select one of the two faces that is the same as the target face, as quickly and as accurately as possible. The dependent variable is the difference in response times for upright vs. inverted faces.

    Time frame: After fMRI on Day 3

  5. Body Image States Scale (BISS)

    This scale consists of six items written to assess the following domains of current body experience: (1) dissatisfaction-satisfaction with one's overall physical appearance; (2) dissatisfaction-satisfaction with one's body size and shape; (3) dissatisfaction-satisfaction with one's weight; (4) feelings of physical attractiveness- unattractiveness; (5) current feelings about one's looks relative to how one usually feels; and (6) evaluation of one's appearance relative to how the average person looks.

    Time frame: Before fMRI on Day 2

  6. Body Image States Scale (BISS)

    This scale consists of six items written to assess the following domains of current body experience: (1) dissatisfaction-satisfaction with one's overall physical appearance; (2) dissatisfaction-satisfaction with one's body size and shape; (3) dissatisfaction-satisfaction with one's weight; (4) feelings of physical attractiveness- unattractiveness; (5) current feelings about one's looks relative to how one usually feels; and (6) evaluation of one's appearance relative to how the average person looks.

    Time frame: After fMRI on Day 2

  7. Body Image States Scale (BISS)

    This scale consists of six items written to assess the following domains of current body experience: (1) dissatisfaction-satisfaction with one's overall physical appearance; (2) dissatisfaction-satisfaction with one's body size and shape; (3) dissatisfaction-satisfaction with one's weight; (4) feelings of physical attractiveness- unattractiveness; (5) current feelings about one's looks relative to how one usually feels; and (6) evaluation of one's appearance relative to how the average person looks.

    Time frame: Before fMRI on Day 3

  8. Body Image States Scale (BISS)

    This scale consists of six items written to assess the following domains of current body experience: (1) dissatisfaction-satisfaction with one's overall physical appearance; (2) dissatisfaction-satisfaction with one's body size and shape; (3) dissatisfaction-satisfaction with one's weight; (4) feelings of physical attractiveness- unattractiveness; (5) current feelings about one's looks relative to how one usually feels; and (6) evaluation of one's appearance relative to how the average person looks.

    Time frame: After fMRI on Day 3

  9. Brain connectivity and activation in the dorsal and ventral visual stream while viewing own faces

    We will obtain fMRI data while participants view photographs of their own face. After preprocessing and analysis we will be able to determine: a) changes in dorsal and ventral visual stream connectivity while naturalistically viewing faces after, compared with before, visual attention modulation. This will be determined for both the fMRI task following iTBS and cTBS. We will also determine, b) associations between changes in brain connectivity with changes in global/local processing (face inversion effect) as a result of iTBS and cTBS.

    Time frame: After TMS on Day 2

  10. Brain connectivity and activation in the dorsal and ventral visual stream while viewing own faces

    We will obtain fMRI data while participants view photographs of their own face. After preprocessing and analysis we will be able to determine: a) changes in dorsal and ventral visual stream connectivity while naturalistically viewing faces after, compared with before, visual attention modulation. This will be determined for both the fMRI task following iTBS and cTBS. We will also determine, b) associations between changes in brain connectivity with changes in global/local processing (face inversion effect) as a result of iTBS and cTBS.

    Time frame: After TMS on Day 3

  11. Brain connectivity and activation in the dorsal and ventral visual stream while viewing scrambled faces

    For an exploratory analysis, we will obtain fMRI data while participants view photographs of scrambled faces, to understand how non-face related visual processing is affected by TMS. After preprocessing and analysis we will be able to determine: a) changes in dorsal and ventral visual stream connectivity while naturalistically viewing faces after, compared with before, visual attention modulation. This will be determined for both the fMRI task following iTBS and cTBS. We will also determine, b) associations between changes in brain connectivity with changes in global/local processing (face inversion effect) as a result of iTBS and cTBS.

    Time frame: After TMS on Day 2

  12. Brain connectivity and activation in the dorsal and ventral visual stream while viewing scrambled faces

    For an exploratory analysis, we will obtain fMRI data while participants view photographs of scrambled faces, to understand how non-face related visual processing is affected by TMS. After preprocessing and analysis we will be able to determine: a) changes in dorsal and ventral visual stream connectivity while naturalistically viewing faces after, compared with before, visual attention modulation. This will be determined for both the fMRI task following iTBS and cTBS. We will also determine, b) associations between changes in brain connectivity with changes in global/local processing (face inversion effect) as a result of iTBS and cTBS.

    Time frame: After TMS on Day 3

07

Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M6J 1H3, Canada
08

References and documents

Publications

  • Wong WW, Rangaprakash D, Larson MS, Diaz-Fong JP, Tadayonnejad R, Leuchter AF, Feusner JD. Can excitatory neuromodulation change distorted perception of one's appearance? Brain Stimul. 2021 Sep-Oct;14(5):1197-1200. doi: 10.1016/j.brs.2021.07.010. Epub 2021 Jul 30. No abstract available. PubMed 34339891 ↗
  • Diaz-Fong JP, Peel HJ, Zhang K, Qian J, Lewis M, Wong WW, Leuchter AF, Tadayonnejad R, Voineskos D, Konstantinou G, Lam E, Blumberger DM, Feusner JD. Effects of theta burst stimulation on neural connectivity and visual perception following attention modification of own-face viewing in body dysmorphic disorder. medRxiv [Preprint]. 2026 May 26:2026.05.25.26354053. doi: 10.64898/2026.05.25.26354053. PubMed 42245010 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2023 to primary completion in Jun 2025, 24 months.

Of 26 interventional studies with no phase under Body Dysmorphic Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 24 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2022
First posted
Nov 7, 2022
StartActual
Jun 30, 2023
Primary completionActual
Jun 30, 2025
CompletionActual
Jun 30, 2025
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05607121
Responsible party
Sponsor
First posted
Nov 7, 2022
Start date
Jun 30, 2023
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Mar 18, 2026

Study contacts

Jamie D Feusner, M.D.
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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