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Behavioural Intervention
TMS for Body Dysmorphic Disorder (EMPAC-BDD Trial)
N/A
Recruiting
Led By Jamie Feusner, M.D.
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after tms on day 3
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the effects of transcranial magnetic stimulation (TMS) on visual processing in adults with body dysmorphic disorder (BDD). TMS uses magnetic fields to stimulate specific brain areas, aiming to improve how these individuals perceive their appearance. The study hopes to find new ways to help people with BDD by enhancing their brain's visual processing capabilities. TMS is a noninvasive technique that has been used for diagnostic and therapeutic purposes in various neuropsychiatric disorders, including depression and bipolar disorder.
Who is the study for?
This trial is for adults aged 18-40 with primary concerns about their face or head appearance, who meet the criteria for Body Dysmorphic Disorder (BDD) according to DSM-5. They should score ≥8 on the Dysmorphic Concern Questionnaire and have a BDD-YBOCS score of ≥20. Participants must not be on medications related to BDD or any other condition for at least 8 weeks before joining.
What is being tested?
The study tests two types of TMS: intermittent and continuous theta burst stimulation, focusing on how they affect visual processing in those with BDD symptoms. Each participant will undergo one type of TMS followed by an fMRI scan while viewing images of their faces, then switch the type of TMS the next day.
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The fMRI procedure is non-invasive but can be uncomfortable due to loud noises and confined space.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after tms on day 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after tms on day 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Image States Scale (BISS)
Brain connectivity and activation in the dorsal and ventral visual stream while viewing own faces
Brain connectivity and activation in the dorsal and ventral visual stream while viewing scrambled faces
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: iTBS then cTBSExperimental Treatment2 Interventions
iTBS day 1, cTBS day 2
Group II: cTBS then iTBSExperimental Treatment2 Interventions
cTBS day 1, iTBS day 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intermittent theta burst stimulation
2020
Completed Phase 2
~220
continuous theta burst stimulation
2011
N/A
~130
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
368 Previous Clinical Trials
82,996 Total Patients Enrolled
University Health Network, TorontoOTHER
1,519 Previous Clinical Trials
503,031 Total Patients Enrolled
Jamie Feusner, M.D.Principal InvestigatorCentre for Addiction and Mental Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with body dysmorphic disorder without severe symptoms.I am 18-40, have intense concerns about my face or head's appearance, and haven't taken any medication for it in the last 8 weeks.I am 18-40, worried about my face or head appearance, and haven't taken any related medication for 8 weeks.I have body dysmorphic disorder but no bipolar, psychotic disorders, or current CBT.
Research Study Groups:
This trial has the following groups:- Group 1: iTBS then cTBS
- Group 2: cTBS then iTBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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