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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
EMPAC-BDD Trial Summary
This trial will test whether TMS can improve visual processing in people with body dysmorphic disorder symptoms.
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.Check my eligibility
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.See study design
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.
EMPAC-BDD Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreEMPAC-BDD 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
356 Previous Clinical Trials
81,418 Total Patients Enrolled
University Health Network, TorontoOTHER
1,476 Previous Clinical Trials
485,140 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical investigation include elderly participants?
"In accordance with the criteria for participant selection, all enrollees must be between 18 years and 40 years of age."
Answered by AI
Are there any qualifications necessary to participate in this research?
"In order to be considered for this clinical trial, applicants must possess body dysmorphic disorder and fall between the ages of 18-40. A maximum of 40 participants will be accepted into the study."
Answered by AI
Are there still opportunities for people to get involved in this research?
"According to the information present on clinicaltrials.gov, this medical study is actively seeking out participants. It was initially posted and last modified on May 19th 2023."
Answered by AI
How many individuals are participating in the experiment?
"Affirmative. Clinicaltrials.gov displays that this research project, initially posted on May 19th 2023 and recently revised on the same date, is currently recruiting patients. 40 individuals are being sought to participate at a single medical facility."
Answered by AI
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