Repetitive Transcranial Magnetic Stimulation (rTMS) versus sham rTMS in Body Dysmorphic Disorder

Recruiting

• Conditions: Body Dysmorphic Disorder; 10037176

• Registration Number: NL-OMON51678
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

1. Age 18 to 65 years old;
2. Diagnosed with Body Dysmorphic Disorder (BDD), based on Body Dysmorphic
Disorder - Yale Brown Obsessive Compulsive Scale (BDD-YBOCS);
3. Nonresponse (defined as <50% response on symptoms measured by the BDD-YBOCS)
after one type of medication treatment, SSRI, maximum dose and adequate
duration;
4. Medication is set 6 weeks prior to the start, and could not be changed
during the study

Exclusion Criteria

Exclusion criteria
1. Intracerebral metal implants (e.g. cochlear implant, brain stimulator);
2. (History of) epilepsy or epilepsy in a first degree relative;
3. Any other neurological disorder with seizure risk;
4. Acute suicidal ideations, or any psychological crisis (contact with the
outpatient crisis service or admission in psychiatric hospital);
5. Bipolar disorder;
6. Current disorder in substance abuse (opiate, ketamine, LSD,
(meth)amphetamine, cocaine, solvents, cannabis, benzodiazepines or barbiturate)
or alcohol abuse;
7. Any known other serious somatic health problem;
8. Pregnancy;
9. Primarily autism spectrum disorder or primarily personality disorder (using
SCID-5-P at baseline for personality disorders). Given that this is often seen
secondarily in BDD patients.

rTMS Contraindications:
1. History of epileptic seizures or epilepsy in a first degree relative,
irregular sleep/ wake rhythm;
2. Cardiac demand pacemakers;
3. Implanted defibrillators;
4. Implanted neurostimulators;
5. Cochlear implants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>More than 30% decrease (defined as response) in BDD-YBOCS questionnaires from<br /><br>baseline till end, and clinical improvement. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore a decrease in BABS, CGI, Sheehan, HDRS and HAS questionnaires are<br /><br>desirable. </p><br>