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Trial registered on ANZCTR


Registration number
ACTRN12615000737538
Ethics application status
Approved
Date submitted
30/06/2015
Date registered
17/07/2015
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Intermittent Theta Burst Stimulation (iTBS) Transcranial Magnetic Stimulation (TMS) for treatment-refractory Body Dysmorphic Disorder (BDD)
Scientific title
Is intermittent Theta Burst Stimulation (iTBS) Transcranial Magnetic Stimulation (TMS) helpful in treatment of Body Dysmorphic Disorder (BDD) in people who do not respond to currently available treatments?
Secondary ID [1] 287019 0
Nil
Universal Trial Number (UTN)
U1111-1171-7150
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment-refractory Body Dysmorphic Disorder 295486 0
Condition category
Condition code
Mental Health 295741 295741 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292226 0
Treatment: Devices
Comparator / control treatment
There is no comparator/control group. The iTBS TMS is an ope-label 6 week adjunct to Treatment as Usual (treatment prescribed by participant’s usual treating clinicians).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295458 0
BDD symptoms will be measured using the Yale Brown Obsessive Compulsive Scale modified for BDD (BDD-YBOCS)
Timepoint [1] 295458 0
The above measure will be done at the beginning of the study and at weekly intervals for the 6 weeks of the acute phase of the study.
The above measure will be repeated at 6 and 12 months after completion of 6 week iTBS TMS course.
Primary outcome [2] 295492 0
Depression will be rated using the Hamilton Scale for Depression (HAM-D)
Timepoint [2] 295492 0
The above measure will be done at the beginning of the study and at weekly intervals for the 6 weeks of the acute phase of the study.
The above measure will be repeated at 6 and 12 months after completion of 6 week iTBS TMS course.
Primary outcome [3] 295493 0
Anxiety will be evaluated using the Hamilton Anxiety Scale (HAM-A)
Timepoint [3] 295493 0
The above measure will be done at the beginning of the study and at weekly intervals for the 6 weeks of the acute phase of the study.
The above measure will be repeated at 6 and 12 months after completion of 6 week iTBS TMS course.
Secondary outcome [1] 315610 0
Obsessive-compulsive symptoms will be measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS)
This is a primary outcome.
Timepoint [1] 315610 0
The above measure will be done at the beginning of the study and at weekly intervals for the 6 weeks of the acute phase of the study.
The above measure will be repeated at 6 and 12 months after completion of 6 week iTBS TMS course.
Secondary outcome [2] 315703 0
The Sheehan Disability Scale will be used to assess overall symptomatic and functional impairment.
This is a primary outcome.
Timepoint [2] 315703 0
The above measure will be done at the beginning of the study and at weekly intervals for the 6 weeks of the acute phase of the study.
The above measure will be repeated at 6 and 12 months after completion of 6 week iTBS TMS course.
Secondary outcome [3] 315704 0
The Brown Assessment of Beliefs Scale (BABS) will be used to assess delusional characteristics of ideation about body morphology.
This is a primary outcome.
Timepoint [3] 315704 0
The above measure will be done at the beginning of the study and at weekly intervals for the 6 weeks of the acute phase of the study.
The above measure will be repeated at 6 and 12 months after completion of 6 week iTBS TMS course.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants must be referred by a treating psychiatrist who has conducted a clinical evaluation of the participant. This includes confirmation of the clinical diagnosis, as well as there having been at least 2 treatments with a selective serotonin reuptake inhibitor (SSRI) at maximum dosage for at least 12 weeks, and at least 1 trial of at least 16 sessions of Cognitive-Behavioural Therapy. Participants’ usual treatment, which may include medication and/or psychological treatment, will be determined and by their treating psychiatrist, who will continue to provide treatment as usual during the study. Participation in the study does not require a change or stopping of usual treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The power will be set at 0.8, with a 20% chance of a type 2 (B) error. The latter involves incorrectly accepting the null hypothesis, that is that there is no difference between pre iTMS and post iTMS stimulation in symptomatic (including a size effect of 0.35 for BDD-YBOCS) parameters in the participants having DBS. With a confidence interval of 95%, utilising non-parametric analyses, the level of statistical significance chosen, p, will be less than or equal to 0.05. Therefore, there is a 5% chance of a type 1 error or false positive.

Comparison at these time points will be via analysis of variance (ANOVA).

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
17/08/2015
Actual
11/04/2016
Date of last participant enrolment
Anticipated
21/06/2019
Actual
11/04/2016
Date of last data collection
Anticipated
20/12/2016
Actual
20/12/2016
Sample size
Target
10
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3992 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 9898 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 291571 0
Hospital
Name [1] 291571 0
St Vincent’s Hospital, Melbourne.
Country [1] 291571 0
Australia
Primary sponsor type
Hospital
Name
St Vincent’s Hospital, Melbourne.
Address
41 Victoria Parade, Fitzroy 3065, Melbourne,Victoria
Country
Australia
Secondary sponsor category [1] 290244 0
None
Name [1] 290244 0
Address [1] 290244 0
Country [1] 290244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293109 0
HREC-D St Vinncent's Hospital Melbourne.
Ethics committee address [1] 293109 0
Ethics committee country [1] 293109 0
Australia
Date submitted for ethics approval [1] 293109 0
Approval date [1] 293109 0
22/06/2015
Ethics approval number [1] 293109 0
HREC-D 087/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58510 0
A/Prof Peter Bosanac
Address 58510 0
St Vincent's Mental Health
PO Box 2900, Fitzroy 3065, Melbourne, Victoria.
Country 58510 0
Australia
Phone 58510 0
+61392314329
Fax 58510 0
Email 58510 0
peter.bosanac@svha.org.au
Contact person for public queries
Name 58511 0
Peter Bosanac
Address 58511 0
St Vincent's Mental Health
PO Box 2900, Fitzroy 3065, Melbourne, Victoria
Country 58511 0
Australia
Phone 58511 0
+61392314329
Fax 58511 0
Email 58511 0
peter.bosanac@svha.org.au
Contact person for scientific queries
Name 58512 0
Peter Bosanac
Address 58512 0
St Vincent's Mental Health
PO Box 2900, Fitzroy 3065, Melbourne, Victoria.
Country 58512 0
Australia
Phone 58512 0
+61392314329
Fax 58512 0
Email 58512 0
peter.bosanac@svha.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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