Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000008123
Ethics application status
Approved
Date submitted
12/12/2018
Date registered
8/01/2019
Date last updated
27/06/2022
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimised Transcranial Magnetic Stimulation (TMS) for Obsessive Compulsive Disorder (OCD)
Scientific title
Optimised Transcranial Magnetic Stimulation for the Treatment of Obsessive Compulsive Disorder
Secondary ID [1] 296806 0
NIL
Universal Trial Number (UTN)
Trial acronym
OTMSOCD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder 310694 0
Condition category
Condition code
Mental Health 309395 309395 0 0
Other mental health disorders
Mental Health 321696 321696 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete an initial clinical and cognitive assessment at the Epworth Centre for Innovation in Mental Health, followed by a baseline imaging session at the Royal Melbourne Hospital. The imaging session will comprise of a resting-state fMRI (rfMRI) paradigm, a structural MR image (T1), a Diffusion Tensor Image (DTI) and a clinical scan. Participants will then be pseudo-randomly assigned to receive (i) optimised TMS (TMS to the right frontal pole (FP), supplementary motor area (SMA) and superior frontal gyrus (SFG)); (ii) non-optimised TMS (stimulation to the right FP alone) or (iii) placebo (sham) stimulation. The optimised condition targets multiple areas in the brain (rFP, SMA,SFG) believed to be involved in OCD symptomology. The non-optimised condition only targets the right FP. Pseudo randomisation will be used to ensure that participants across the three groups are match on age, gender, handedness, IQ and baseline symptom severity score. Within the week following the MRI scan, participants will begin a 3-week protocol of TMS called continuous theta burst stimulation (cTBS). cTBS will be provided as 3-pulse 50 - Hz bursts applied at 5 Hz (ie 50 Hz burst of 3 pulses delivered every 200 msec). The TMS intervention itself will go for between 40 seconds and approximately 2 minutes depending on the treatment condition. The TMS treatment will be administered by registered nurses. Participants will not be told which treatment group (optimal, non-optimal, sham) they have been assigned to, and all 3 conditions (2 active, 1 sham) will have a similar duration and dose to avoid unblinding.
Intervention code [1] 313096 0
Treatment: Devices
Comparator / control treatment
A placebo (sham) condition will be utilised as a control/comparator treatment and a specialised sham TMS coil will be used, This coil does not generate enough power to stimulate the brain, however it looks, feels and sounds like the active TMS coil. If allocated to this condition, participants will attend the Epworth Centre for Innovation in Mental Health for three weeks of daily treatment. However they will not receive active treatment. The coil used in the sham condition will be different from the active TMS coil. After the three month wash out period, those initially in the sham condition will go to the optimal condition and receive active treatment for 3 weeks. Participants will not be told which treatment group (optimal, non-optimal, sham) they have been assigned to, and all 3 conditions (2 active, 1 sham) will have a similar duration and dose to avoid unblinding.
Control group
Placebo

Outcomes
Primary outcome [1] 308350 0
Difference in Yale and Brown Obsessive Compulsive Scale (Y-BOCS) score
Timepoint [1] 308350 0
Baseline and end of treatment
Primary outcome [2] 308465 0
Differences in fronto-striatal functional connectivity as assessed by fMRI
Timepoint [2] 308465 0
Baseline and end of treatment
Secondary outcome [1] 354681 0
Belief domains of the Obsessive Beliefs Questionnaire-44 (OBQ-44)
Timepoint [1] 354681 0
Baseline and end of treatment
Secondary outcome [2] 354682 0
The Obsessive–Compulsive Inventory, short version (OCI-R)
Timepoint [2] 354682 0
Baseline and end of treatment
Secondary outcome [3] 354683 0
Montgomery Asberg Depression Rating Scale (MADRS)
Timepoint [3] 354683 0
Baseline and Endpoint
Secondary outcome [4] 354684 0
Hamilton Anxiety Rating Scale (HAM-A)
Timepoint [4] 354684 0
Baseline and End of treatment
Secondary outcome [5] 354685 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [5] 354685 0
Baseline and end of treatment

Eligibility
Key inclusion criteria
1. Age of 18 to 65 years inclusive?
2. Does the patient have a primary diagnosis of Obsessive-Compulsive Disorder (OCD) according to the DSM-V criteria?
3. Does the patient currently score between 17-31 (ie. Moderate to severe) on the Yale and Brown Obsessive Compulsive Scale (Y-BOCS)?
** Please Note: completion of the Y-BOCS is not a required prerequisite for the Clinical Trial, but rather a gauge on the severity of symptoms that we require for participation. We will assess the patient on this measure as part of the clinical assessments. If you have not completed the Y-BOCS with the patient but they have moderate to severe OCD symptoms, please circle N/A.
4. Has the patient had a diagnosis of OCD for a period greater than 12 months?
5. Does the patient have the capacity to give informed consent to participate in the clinical trial?
6. Will the patient be able to attend the Epworth Centre for Innovation in Mental Health (Mon-Fri) for 3 weeks?
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Does the patient have any contraindication to having a magnetic resonance imaging (MRI)?
2. Does the patient have any contraindication to having transcranial magnetic stimulation (TMS)?
3. Has the patient ever been diagnosed with a psychotic disorder?
4. Has the patient ever been diagnosed with Bipolar I or II?
5. Does the patient have any medical condition that would interfere with treatment?
6. Has the patient’s pharmaceutical treatment changed in the past three months?
7. Does the patient have Tourette’s syndrome?
8. Has the patient ever suffered from a substance abuse disorder or alcohol/drug misuse?
9. Is the participant pregnant or planning to become pregnant during the duration of the trial?

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
Due to disruptions in recruitment and testing caused by the COVID-19 pandemic, the study funding ran out prior to reaching the target sample size. The study was therefore stopped early.
Date of first participant enrolment
Anticipated
31/05/2019
Actual
24/06/2019
Date of last participant enrolment
Anticipated
Actual
11/01/2022
Date of last data collection
Anticipated
Actual
17/06/2022
Sample size
Target
80
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12663 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 25082 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 301379 0
Government body
Name [1] 301379 0
National Health and Medical Research Council
Country [1] 301379 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University,
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 301048 0
None
Name [1] 301048 0
Address [1] 301048 0
Country [1] 301048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302117 0
Alfred Health
Ethics committee address [1] 302117 0
Ethics committee country [1] 302117 0
Australia
Date submitted for ethics approval [1] 302117 0
05/11/2018
Approval date [1] 302117 0
19/02/2019
Ethics approval number [1] 302117 0
604/18

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

Contacts
Principal investigator
Name 89170 0
Prof Paul Fitzgerald
Address 89170 0
Epworth Centre for Innovation in Mental Health
888 Toorak Rd, Camberwell VIC 3124
Country 89170 0
Australia
Phone 89170 0
+61 3 9805 4287
Fax 89170 0
Email 89170 0
paul.fitzgerald@monash.edu
Contact person for public queries
Name 89171 0
Oscar Murphy
Address 89171 0
Epworth Centre for Innovation in Mental Health
888 Toorak Rd, Camberwell VIC 3124
Country 89171 0
Australia
Phone 89171 0
+61 3 9805 4387
Fax 89171 0
Email 89171 0
oscar.murphy@monash.edu
Contact person for scientific queries
Name 89172 0
Luca Cocchi
Address 89172 0
QIMR Berghofer Medical Research Institute
300 Herson Road,
4006 Queensland
Country 89172 0
Australia
Phone 89172 0
+61 7 38453008
Fax 89172 0
Email 89172 0
Luca.Cocchi@qimrberghofer.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Sociodemographic (e.g., age, gender, handedness), cognitive (e.g., IQ), clinical (e.g.,
severity of symptoms), physiological (e.g., threshold of brain stimulation, heart rate) and imaging
data.
When will data be available (start and end dates)?
As per the study protocol, data will not be shared until the manuscript is accepted for publication. The start date of IPD availability will be dependent on when the study has been published. There is no end date for IPD availability.
Available to whom?
The study protocol and PICF allows for the data to be shared with other researchers as part of data sharing initiatives. This would include uploading de-identified (i.e. anonymised) data to a secure server as part of a data sharing initiative to facilitate research discoveries. The anonymised data may be shared with researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Data will be available for analyses which serve the purposes outlined in the aims of the approved proposal. Data may also be provided upon request for use in IPD meta-analyses.
How or where can data be obtained?
As per the study protocol, data will not be shared until the manuscript is accepted for publication. Once this has been completed, data may be obtained via contacting the study PI:
Associate Professor Luca Cocchi
+61 7 3845 3008
luca.cocchi@qimrberghofer.edu.au


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
No additional documents have been identified.