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TMS Visual Modulation in Body Dysmorphic Disorder (EMPAC-BDD)

Primary Purpose

Body Dysmorphic Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
intermittent theta burst stimulation
continuous theta burst stimulation
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Body Dysmorphic Disorders focused on measuring transcranial magnetic stimulation, visual processing, brain connectivity, theta burst stimulation, fMRI

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Body dysmorphic disorder: Inclusion: 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 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).

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

iTBS then cTBS

cTBS then iTBS

Arm Description

iTBS day 1, cTBS day 2

cTBS day 1, iTBS day 2

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2022
Last Updated
October 4, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05607121
Brief Title
TMS Visual Modulation in Body Dysmorphic Disorder
Acronym
EMPAC-BDD
Official Title
Exogenous Modulation of Visual Perception and Connectivity in Body Dysmorphic Disorder (EMPAC-BDD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorders
Keywords
transcranial magnetic stimulation, visual processing, brain connectivity, theta burst stimulation, fMRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTBS then cTBS
Arm Type
Experimental
Arm Description
iTBS day 1, cTBS day 2
Arm Title
cTBS then iTBS
Arm Type
Experimental
Arm Description
cTBS day 1, iTBS day 2
Intervention Type
Device
Intervention Name(s)
intermittent theta burst stimulation
Intervention Description
transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
continuous theta burst stimulation
Intervention Description
transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Face inversion effect
Description
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
Title
Face inversion effect
Description
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
Title
Face inversion effect
Description
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
Title
Face inversion effect
Description
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
Title
Body Image States Scale (BISS)
Description
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
Title
Body Image States Scale (BISS)
Description
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
Title
Body Image States Scale (BISS)
Description
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
Title
Body Image States Scale (BISS)
Description
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
Title
Brain connectivity and activation in the dorsal and ventral visual stream while viewing own faces
Description
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
Title
Brain connectivity and activation in the dorsal and ventral visual stream while viewing own faces
Description
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
Title
Brain connectivity and activation in the dorsal and ventral visual stream while viewing scrambled faces
Description
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
Title
Brain connectivity and activation in the dorsal and ventral visual stream while viewing scrambled faces
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
We will ask participants to report their identified gender.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body dysmorphic disorder: Inclusion: 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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Strazds
Phone
4165358501
Ext
32395
Email
bdd.empac@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Darren Liang
Phone
4165358501
Ext
39368
Email
darren.liang@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie D Feusner, M.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie D Feusner, M.D.
Phone
(416) 535-8501
Ext
33436
Email
jamie.feusner@camh.ca
First Name & Middle Initial & Last Name & Degree
Jamie D Feusner, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
34339891
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9007239/
Description
Published manuscript of the pilot study

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TMS Visual Modulation in Body Dysmorphic Disorder

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