TMS Visual Modulation in Body Dysmorphic Disorder

NCT05607121 | Completed

• 1 other identifier: R21MH128815
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Dysmorphic Disorders

Keywords

transcranial magnetic stimulation; visual processing; brain connectivity; theta burst stimulation; fMRI

Outcome Measures

Primary Outcomes (12)

• 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.

  Before TMS on Day 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.

  After fMRI on Day 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.

  Before TMS on Day 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.

  After fMRI on Day 3

• 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.

  Before fMRI on Day 2

• 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.

  After fMRI on Day 2

• 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.

  Before fMRI on Day 3

• 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.

  After fMRI on Day 3

• 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.

  After TMS on Day 2

• 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.

  After TMS on Day 3

• 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.

  After TMS on Day 2

• 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.

  After TMS on Day 3

Study Arms (2)

iTBS then cTBS

EXPERIMENTAL

iTBS day 1, cTBS day 2

Device: intermittent theta burst stimulation; Device: continuous theta burst stimulation

cTBS then iTBS

EXPERIMENTAL

cTBS day 1, iTBS day 2

Device: intermittent theta burst stimulation; Device: continuous theta burst stimulation

Interventions

intermittent theta burst stimulation DEVICE

transcranial magnetic stimulation

cTBS then iTBS; iTBS then cTBS

continuous theta burst stimulation DEVICE

transcranial magnetic stimulation

cTBS then iTBS; iTBS then cTBS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: We will ask participants to report their identified gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body dysmorphic disorder:
• males or females
• ages 18-40
• meet Diagnostic and Statistical Manual (DSM-5) 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H3, Canada

Location

Related Publications (1)

• 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.

  PMID: 34339891 BACKGROUND

Related Links

• Published manuscript of the pilot study

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Jamie D Feusner, M.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: November 7, 2022
• Study Start: June 30, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 18, 2026

Record last verified: 2025-11

Locations

CA (1)