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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51678
Enrollment
56
Registered
2022-05-18
Start date
2022-09-05
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Dysmorphic Disorder

Interventions

The study consist of two groups, one rTMS and one sham rTMS. Both will be treated with a high frequency 10 Hz rTMS (HF-rTMS) protocol on the left dorsolateral prefrontal cortex (dlPFC). rTMS treatme

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
More than 30% decrease (defined as response) in BDD-YBOCS questionnaires from baseline till end, and clinical improvement.

Secondary

MeasureTime frame
Furthermore a decrease in BABS, CGI, Sheehan, HDRS and HAS questionnaires are desirable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)