None listed
Conditions
Brief summary
Body Dysmorphic Disorder (BDD) affects approximately 2% of the population and involves constant worry and distress about how someone thinks and feels that they look. About 40% of people with BDD do not respond to currently available treatments. In BDD, there appear to be abnormalities in the activity of some areas of the brain, including areas responsible for visual processing. To date there have been no studies evaluating whether transcranial stimulation (TMS) is helpful for people with ongoing and distressing symptoms of BDD, including those who have not responded to other treatments. Hence, the aim of this study is to determine whether TMS is helpful in the treatment of people experiencing BDD, aged 18-65 years, who have not responded to currently available treatments. TMS uses electric currents to generate magnetic fields which can be used to stimulate the brain. This technique is non-invasive (does not require surgery or the introduction of instruments into the body) and requires no anaesthesia or hospital stay/treatment. The TMS in the study will stimulate the areas of the brain responsible for visual processing, which may be functioning abnormally in BDD, over a 6 week period. Participation in the study does not require a change or stopping of usual treatment, which may include medication and/or psychological treatment, determined by participants' consultation with their treating psychiatrists.
Interventions
Open-label, proof of concept study in initially 10 participants, providing informed consent, to assess whether intermittent theta burst stimulation (iTBS) transcranial magnetic stimulation (TMS) is efficacious as an adjunct to treatment as usual (treatment prescribed by participant’s usual treating clinicians) in patients with treatment-refractory BDD. iTBS TMS will be conducted five times per week, for 6 weeks. No lead in time required preceding 6 week trial, nor taper period required after 6 w
Open-label, proof of concept study in initially 10 participants, providing informed consent, to assess whether intermittent theta burst stimulation (iTBS) transcranial magnetic stimulation (TMS) is efficacious as an adjunct to treatment as usual (treatment prescribed by participant’s usual treating clinicians) in patients with treatment-refractory BDD. iTBS TMS will be conducted five times per week, for 6 weeks. No lead in time required preceding 6 week trial, nor taper period required after 6 week trial as treatment as usual continued throughout. The iTBS TMS protocol consists of bursts of three pulses given at 50 Hz repeated every 200 ms, mimicking the coupling of theta and gamma rhythms. Stimulation intensity used in this protocol is the 80% of the active motor threshold (AMT). The intermittent iTBS consists of 1,840 ms of stimulation repeated every 10 s for a total of 191.84 s (600 pulses). Hence there are approximately 15 pulses a second, delivered in a 2 second on / 8 second off pattern for a little over 3 minutes. Treatment will occur Monday to Friday and will require approximately 3 minutes for the TMS itself, and up to 20 minutes for each visit. Targetting will be via the International 10-20 electrode placement system and/or neuronavigation system of left intracalcarine cortex and occipital pole (Brodmann areas 17[primary visual cortex] and 18[secondary visual cortex]). Neuronavigation will require a baseline MRI brain.
Sponsors
St Vincent’s Hospital, Melbourne.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
18-65 years. DSM-5 criteria for BDD, and clinical psychiatric evaluation. Treatment refractoriness: no response or insufficient response following at least 2 treatments with a selective serotonin reuptake inhibitor (SSRI) at maximum dosage for at least 12 weeks, plus at least 1 Cognitive-Behavioural Therapy (CBT) trial for a minimum of 16 sessions (Phillips, 2008). 20 or higher on the BDD version on the Yale-Brown Obsessive Compulsive Scale for Body Dysmorphic Disorder (BDD YBOCS).
Exclusion criteria
Active substance abuse, neurological disorder including a history of seizures or epilepsy, pregnancy, or any current medical disorder that may affect cerebral metabolism; or acutel suicidality. Also: cochlear implants; metallic implants in the brain or elsewhere (splinters, clips, fragments); an implanted neurostimulator (deep brain stimulator, vagal nerve stimulator, epidural/subdural stimulator); cardiac pacemaker or intracardiac line; or medication infusion device.
Outcome results
None listed