Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000780752
Ethics application status
Approved
Date submitted
19/06/2013
Date registered
12/07/2013
Date last updated
24/06/2022
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcranial magnetic stimulation for obsessive compulsive disorder
Scientific title
Neuronavigationally Targeted rTMS in Treatment Resistant Obsessive Compulsive Disorder
Secondary ID [1] 282619 0
Nil
Universal Trial Number (UTN)
Trial acronym
rTMS for OCD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive compulsive disorder 289310 0
Condition category
Condition code
Mental Health 289647 289647 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a 30-minute repetitive transcranial magnetic stimulation (rTMS) treatment each week day for four weeks (20 treatments in total).

rTMS will be delivered with a Medtronic Magpro stimulator at 1 Hz and 120% of motor threshold in one continuous train of 30 minutes duration (1800 pulses per day).
Intervention code [1] 287285 0
Treatment: Devices
Comparator / control treatment
The clinical efficacy of rTMS delivered to two different brain areas will be compared:

1. right hemispheric premotor cortex

versus

2. bilateral supplementary motor area

Each participant will receive treatment at one (not both) of these brain sites.
Control group
Active

Outcomes
Primary outcome [1] 289728 0
Yale–Brown Obsessive–Compulsive Scale
Timepoint [1] 289728 0
Following 20th treatment.
Secondary outcome [1] 303119 0
Beck Depression Inventory - II
Timepoint [1] 303119 0
Following 20th treatment
Secondary outcome [2] 303120 0
Beck Anxiety Inventory
Timepoint [2] 303120 0
Following 20th treatment
Secondary outcome [3] 303121 0
Clinical Global Impression
Timepoint [3] 303121 0
Following 20th treatment

Eligibility
Key inclusion criteria
1. Have a DSM-IV diagnosis of an obsessive compulsive disorder.

2. Have treatment resistance as defined by a failure to respond to at least two trials of adequate dose and duration of appropriate medications (serotonin reuptake inhibitor medications or clomipramine).

3. Have had no increase or initiation of new medication therapy in the 6 weeks prior to screening.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating.

2. Have a current DSM IV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder except depression or another anxiety disorder.

3. Any contraindication to TMS or MRI scanning.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/08/2013
Actual
22/10/2013
Date of last participant enrolment
Anticipated
Actual
1/02/2016
Date of last data collection
Anticipated
1/03/2016
Actual
Sample size
Target
60
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287399 0
University
Name [1] 287399 0
Monash Alfred Psychiatry Research Centre
Country [1] 287399 0
Australia
Funding source category [2] 287593 0
University
Name [2] 287593 0
Monash Clinical Imaging and Neuroscience
Country [2] 287593 0
Australia
Primary sponsor type
University
Name
Monash Alfred Psychiatry Research Centre
Address
Level 4, 607 St Kilda Rd
Prahran VIC
3181
Country
Australia
Secondary sponsor category [1] 286140 0
None
Name [1] 286140 0
Address [1] 286140 0
Country [1] 286140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289377 0
The Melbourne Clinic Research Ethics Committee
Ethics committee address [1] 289377 0
130 Church Street
Richmond, 3121
VIC
Ethics committee country [1] 289377 0
Australia
Date submitted for ethics approval [1] 289377 0
12/06/2013
Approval date [1] 289377 0
21/08/2013
Ethics approval number [1] 289377 0

Summary
Brief summary
A number of small studies have investigated the therapeutic potential of repetitive transcranial magnetic stimulation (rTMS) for OCD by stimulating an area of the frontal lobe called the DLPFC. On the whole, the results of these studies have not been encouraging.

The current project aims to compare the clinical efficacy of rTMS for OCD at two promising novel treatment targets: right sided premotor cortex versus bilateral supplementary motor area.

Participation in the trial involves having two MRI brain scans and four weeks of inpatient rTMS treatment in Melbourne, Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40526 0
Prof Paul Fitzgerald
Address 40526 0
Monash Alfred Psychiatry Research Centre (MAPrc)
Level 4, 607 St Kilda Rd
Prahran, 3004
VIC
Country 40526 0
Australia
Phone 40526 0
+61 3 9076 6564
Fax 40526 0
Email 40526 0
[email protected]
Contact person for public queries
Name 40527 0
Dr Rebecca Segrave
Address 40527 0
MAPrc
Level 4, 607 St Kilda Rd
Prahran, 3004
VIC
Country 40527 0
Australia
Phone 40527 0
+61 3 9076 6564
Fax 40527 0
Email 40527 0
[email protected]
Contact person for scientific queries
Name 40528 0
Dr Rebecca Segrave
Address 40528 0
MAPrc
Level 4, 607 St Kilda Rd
Prahran, 3004
VIC
Country 40528 0
Australia
Phone 40528 0
+61 3 9076 6564
Fax 40528 0
Email 40528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Publication date: 3 February 2022 (available onl... [More Details] 364367-(Uploaded-22-06-2022-12-59-57)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot study of fMRI targeted rTMS for obsessive compulsive disorder.2022https://dx.doi.org/10.1016/j.brs.2022.02.019
N.B. These documents automatically identified may not have been verified by the study sponsor.