The main objective of this study is to investigate whether rTMS treatment will improve clinical outcomes in body dysmorphic disorder, by reducing BDD YBOCS outcomes. Furthermore to improve localization and rTMS treatment in the dorsolateral…
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Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
More than 30% decrease (defined as response) in BDD-YBOCS questionnaires from
baseline till end, and clinical improvement.
Secondary outcome
Furthermore a decrease in BABS, CGI, Sheehan, HDRS and HAS questionnaires are
desirable.
Background summary
Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive
neuromodulating therapy, in which magnetic pulses given to cortical regions
lead to changes in brain circuits involved in psychiatric disorders. rTMS is an
emerging, evidence based and safe treatment option for major depressive
disorder (MDD). Response rates for depression are estimated between 28 to 83%,
depending on the protocol, cortical location, refractoriness or combined
therapy. Furthermore there is current evidence that rTMS is an effective
intervention in obsessive-compulsive disorder. It may be also a potential
treatment option for other conditions, such as schizophrenia and substance
abuse disorders.
A recent case series, by our research group, showed that when combining rTMS
with medication and cognitive behavioral therapy (CBT), this has an additive
effect on reducing depressive and more important, also body dysmorphic
symptoms. The hypothesis behind this catalytic effect is that depressive
networks can be coupled, after which rTMS induced neuroplasticity and its
antidepressant effects may spread over networks throughout the brain during
stimulation.
In individuals with body dysmorphic disorder (BDD) there is a preoccupation
with non-existent or minor imperfections in their appearance. Even when there
is a presence of visible blemishes, BDD could still be diagnosed. Obsessive
thoughts, repetitive compulsions, regularly checking or seeking for
reassurance, could completely control the life of these individuals. This
mental disorder is frequently associated with disturbing psychosocial
impairment, depressive and anxiety comorbidity and even suicidality. Current
evidence-based treatment options are psychotherapy (cognitive based therapy
(CBT)) or antidepressant medication as SSRI*s. In 60-70% treatment is
effective. Nevertheless there are opportunities for improvement in BDD
treatment and neuromodulation is very scarce. We therefore propose a cross-over
study design in BDD patients focusing on the clinical effect of rTMS.
Study objective
The main objective of this study is to investigate whether rTMS treatment will
improve clinical outcomes in body dysmorphic disorder, by reducing BDD YBOCS
outcomes. Furthermore to improve localization and rTMS treatment in the
dorsolateral prefrontal cortex (dlPFC). Our secondary objectives will be to
answer the questions what the effect of real rTMS treatment compared to sham
rTMS treatment regarding psychological state (depression, anxiety) is. What the
effect of rTMS treatment compared to sham rTMS treatment on preparation for
cognitive behavioral therapy is and what the effect is of rTMS in the
neurobiological mechanisms involved in BDD.
Study design
It will be a randomized controlled trial, with one group receiving rTMS
treatment, and the other group sham rTMS, to see whether rTMS will improve
their clinical and treatment outcome. They will be stimulated over the left
dorsolateral prefrontal cortex (left-dlPFC). Individuals receiving real rTMS
treatment will probably benefit.
Intervention
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 treatment will be given for 15
times, once a day, 5 days/week, for 3 weeks. We will use several
questionnaires, BDD-YBOCS, BABS, Sheehan, CGI, HDRS and HAS, every 5th rTMS
session or sham rTMS session.
Study burden and risks
The risk and burden associated with participation can be considered minimal. In
the clinical trial there will be 15 rTMS stimulation sessions on subsequent
workdays. One session includes 5 minutes of preparation, 20-30 minutes of
stimulation, with a total of 30-35 minutes per session. Psychometrics will be
taken every 5th session, with a total of 30 minutes for all questionnaires. The
first baseline session will be (maximum) 1:30h, due to measurements and
technical procedures, psychometrics, ECG and vitals. Furthermore, in all
patients structured diagnostic interviews will be administered before start.
Minimal risk is associated with participation in this study. The risks
associated with the stimulation are very low, as rTMS was shown non-invasive,
safe and tolerable in large trials. All side-effects are mild and of short
duration. The most common side-effects are neckpain/discomfort (±40%), local
discomfort of the scalp (±39%), tension headaches during and after stimulation
(±28%) and dizziness. The pain and discomfort mainly occur during the first
sessions, and become less as the number of treatments progresses. The most
severe - but extremely rare - side-effect is a seizure. The prevalence is
7:100.000 sessions.
Meibergdreef 5
Amsterdam 1105 AZ
NL
Meibergdreef 5
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79989.018.22 |