Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001687482
Ethics application status
Approved
Date submitted
5/12/2016
Date registered
8/12/2016
Date last updated
10/09/2023
Date data sharing statement initially provided
30/06/2021
Date results provided
10/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of focal non-invasive brain stimulation on network dynamics and symptoms of Obsessive-Compulsive Disorder
Scientific title
Effects of focal non-invasive brain stimulation on network dynamics and symptoms of Obsessive-Compulsive Disorder
Secondary ID [1] 290679 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder 301217 0
Condition category
Condition code
Mental Health 300974 300974 0 0
Anxiety
Mental Health 301000 301000 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete an initial neurocognitive assessment, clinical interview and a baseline imaging session. Physiological measurements, such as heart rate, skin conductance and breathing will be recorded during the imaging session via an ECG and GSR sensor. Participants will then be pseudo-randomly assigned to either the 'active' Transcranial Magnetic Stimulation (TMS) group or the placebo TMS group. Following the scan, participants will begin a 4-week protocol of repetitive TMS. TMS will be administered by trained personnel. Participants in the active TMS condition will undergo a 600-pulses theta burst stimulation to the prefrontal cortex. This procedure will involve the participant coming to the QIMR Berghofer Medical Research Institute five days per week (Mon-Fri) for a ~45min TMS session and AE assessment. After the 4-week TMS regime, participants will undergo a second imaging session, immediately followed by a final clinical assessment. Six months after completion of the intervention, participants will participate in a follow-up cognitive assessment.
Intervention code [1] 296565 0
Treatment: Devices
Intervention code [2] 296579 0
Treatment: Other
Comparator / control treatment
Placebo stimulation will be administered with a specific coil that is made by the same manufacturer. This coil mimics the noise and effects of the real TMS but does not affect the neural activity of the targeted area.

Participant coming to the QIMR Berghofer Medical Research Institute five days per
week (Mon-Fri) for a 30-45min TMS session.
Control group
Placebo

Outcomes
Primary outcome [1] 300404 0
Changes in functional brain connectivity between the striatum and the TMS cortical target assessed using magnetic resonance imaging. The baseline and post-intervention imaging sessions will be used.
Timepoint [1] 300404 0
Baseline and 4 weeks
Primary outcome [2] 300405 0
Changes in Y-BOCS score after the TMS intervention. The Y-BOCS is a 10-item scale administered as a semi structured interview. The scale assesses the severity of obsessions and compulsions. The Y-BOCS is the standard test to evaluate OCD.
Timepoint [2] 300405 0
Baseline, 4 weeks and 6 months. (The cognitive assessment will take place pre and post TMS intervention, as well as 6 months after the intervention.)
Primary outcome [3] 300435 0
Changes in structural brain connectivity between the striatum and the TMS cortical target assessed using magnetic resonance imaging. The baseline and post-intervention imaging sessions will be used.
Timepoint [3] 300435 0
Baseline and 4 weeks
Secondary outcome [1] 329893 0
* Belief domains of the Obsessive Beliefs Questionnaire-44 (OBQ-44)
Timepoint [1] 329893 0
Baseline, week 4 and 6 months.
Secondary outcome [2] 329924 0
*The Obsessive–Compulsive Inventory, short version (OCI-R)
Timepoint [2] 329924 0
Baseline, week 4 and 6 months.
Secondary outcome [3] 329925 0
*Montgomery Asberg Depression Scale (MADS)
Timepoint [3] 329925 0
Baseline, week 4 and 6 months.
Secondary outcome [4] 329926 0
*Hamilton Anxiety Rating Scale (HAM_A)
Timepoint [4] 329926 0
Baseline, week 4 and 6 months.
Secondary outcome [5] 329927 0
*Hospital Anxiety and Depression Scale (HADS)
Timepoint [5] 329927 0
Baseline, week 4 and 6 months.
Secondary outcome [6] 329928 0
*Weischler Intelligence Scale (WAS-II)
Timepoint [6] 329928 0
Baseline, week 4 and 6 months.

Eligibility
Key inclusion criteria
To be eligible for participation in the study, male and female participants must meet
all the following criteria:
1. Age: 18-50
2. Diagnosis of primary Obsessive-compulsive disorder (OCD) according to
the DSM-V criteria.
3. Yale and Brown Obsessive Compulsive scale (Y-BOCS) score between
17 and 31 (i.e., moderate to severe symptomatology).
4. Duration of OCD greater than 1 year.
5. Participants must be able to provide informed consent
6. Participants must be available to come to QIMRB daily (Mon-Fri) for 4
weeks. The TMS stimulation will take approximatively 30-45 minutes.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be ineligible for recruitment if they:
*have had a change to pharmaceutical treatment in the past month.
*are pregnant or trying to fall pregnant?
*ever attempted suicide?
*ever been diagnosed with a psychotic disorder?
*ever experienced a manic episode?
*ever experienced a spontaneous seizure?
*has a neurological disorder?
*ever experienced a traumatic head injury?
*ever been diagnosed with a substance abuse disorder or alcohol/drug misuse?
*suffers from claustrophobia?

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2016
Actual
21/04/2017
Date of last participant enrolment
Anticipated
Actual
30/07/2021
Date of last data collection
Anticipated
Actual
30/04/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 295112 0
Government body
Name [1] 295112 0
National Health & Medical Research Council (NHMRC)
Country [1] 295112 0
Australia
Primary sponsor type
Other Collaborative groups
Name
QIMR Berghofer Medical Research Institute
Address
300 Herston Rd, Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 293931 0
None
Name [1] 293931 0
Address [1] 293931 0
Country [1] 293931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296464 0
QIMR Berghofer Human Research Ethics Committee
Ethics committee address [1] 296464 0
Ethics committee country [1] 296464 0
Australia
Date submitted for ethics approval [1] 296464 0
29/11/2016
Approval date [1] 296464 0
08/12/2016
Ethics approval number [1] 296464 0
P2253
Ethics committee name [2] 296465 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [2] 296465 0
Ethics committee country [2] 296465 0
Australia
Date submitted for ethics approval [2] 296465 0
19/05/2016
Approval date [2] 296465 0
23/11/2016
Ethics approval number [2] 296465 0

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

Contacts
Principal investigator
Name 70454 0
Dr Luca Cocchi
Address 70454 0
QIMR Berghofer Medical Institute
Bancroft Building, Level 12, 300 Herston Road
Brisbane QLD 4006
Country 70454 0
Australia
Phone 70454 0
+617 3845 3008
Fax 70454 0
Email 70454 0
[email protected]
Contact person for public queries
Name 70455 0
Luca Cocchi
Address 70455 0
QIMR Berghofer Medical Institute
Bancroft Building, Level 12, 300 Herston Road
Brisbane QLD 4006
Country 70455 0
Australia
Phone 70455 0
+61738453008
Fax 70455 0
Email 70455 0
[email protected]
Contact person for scientific queries
Name 70456 0
Luca
Address 70456 0
QIMR Berghofer Medical Institute
Bancroft Building, Level 12, 300 Herston Road
Brisbane QLD 4006
Country 70456 0
Australia
Phone 70456 0
+61738453008
Fax 70456 0
Email 70456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data for research purposes are available on request ([email protected]). Data can only be shared on request due to restrictions laid out in the study’s participant consent forms and QIMR Berghofer data protection policies. Data will be made available after a data-sharing agreement with QIMR Berghofer has been signed.
When will data be available (start and end dates)?
Immediately following publication with no end date determined
Available to whom?
Researchers
Available for what types of analyses?
Any purpose
How or where can data be obtained?
De-identified participant data for research purposes are available on request ([email protected]). Data can only be shared on request due to restrictions laid out in the study’s participant consent forms and QIMR Berghofer data protection policies. Data will be made available after a data-sharing agreement with QIMR Berghofer has been signed.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20303Study protocol  [email protected]
20304Statistical analysis plan  [email protected]
20305Ethical approval  [email protected]
20306Analytic code  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMechanisms of imbalanced frontostriatal functional connectivity in obsessive-compulsive disorder.2023https://dx.doi.org/10.1093/brain/awac425
EmbaseRevisiting deficits in threat and safety appraisal in obsessive-compulsive disorder.2023https://dx.doi.org/10.1002/hbm.26518
N.B. These documents automatically identified may not have been verified by the study sponsor.