Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000666426
Ethics application status
Approved
Date submitted
27/04/2016
Date registered
23/05/2016
Date last updated
23/05/2022
Date data sharing statement initially provided
23/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Theta Burst Stimulation (TBS) in Treatment Resistant Obsessive Compulsive Disorder.
Scientific title
Theta Burst Stimulation (TBS) in Treatment Resistant Obsessive Compulsive Disorder.
Secondary ID [1] 289012 0
Nil
Universal Trial Number (UTN)
U1111-1199-6860
Trial acronym
TBS for OCD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder 298423 0
Condition category
Condition code
Mental Health 298518 298518 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is a parallel group clinical trial where participants will receive bilateral TBS to either the orbital frontal cortex (OFC) or the supplementary motor area (SMA). Each treatment course will involve TBS treatment twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate treatment one month after their initial treatment had ended.

During treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation. TBS will be applied in a single 40 - second train per application. Three pulses per burst will be applied at 50 Hz and the bursts repeated at 5 Hz. The treatment intensity for both rTMS and TBS will be 120% of resting motor threshold which is measured by administering single pulse TMS to the muscle controlling area of the brain.
Intervention code [1] 294495 0
Treatment: Devices
Comparator / control treatment
Two treatment arms (TBS to SMA and TBS to OFC) are both considered intervention arms, with neither to be allocated as the control.
Control group
Active

Outcomes
Primary outcome [1] 298072 0
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Timepoint [1] 298072 0
The YBOCS will be administered at baseline, at week 2 post start of treatment and at 4 - 6 weeks post treatment completion.
Secondary outcome [1] 323085 0
Beck Depression Inventory (BDI)
Timepoint [1] 323085 0
The BDI will be administered at baseline, at week 2 post start of treatment and at 4 - 6 weeks post treatment completion.
Secondary outcome [2] 323086 0
Beck Anxiety Inventory (BAI)
Timepoint [2] 323086 0
The BAI will be administered at baseline, at week 2 post start of treatment and at 4 - 6 weeks post treatment completion.
Secondary outcome [3] 323087 0
The Clinical Global Impression (CGI) scale.
Timepoint [3] 323087 0
The CGI will be administered at baseline, at week 2 post start of treatment and at 4 - 6 weeks post treatment completion.

Eligibility
Key inclusion criteria
- Have DSM-5 diagnosis of OCD
- Are treatment resistant
- Have had no changes in medications in 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
- An unstable medical condition, neurological disorder, history of seizure disorder or currently pregnant or lactating
-A current diagnosis of substance abuse or dependence, a personality disorder or other psychiatric disorder, except depression or another anxiety disorder
- Any contraindication to TMS

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)
The treatment group is determined by a computer program that generates random numbers. The researcher with access to this program and who is not involved in patient selection securely provides the treatment group to a member of the treatment team by email or in a sealed envelope. The staff member in receipt of the treatment group is not involved in assessing a patient's eligibility at the baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to one of two treatment conditions will occur via the generation of a single computer number sequence (no stratification).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be conducted on YBOCS scores from baseline to week 2. Student t tests and Chi-squared tests will be used to examine for differences between demographic and clinical characteristics between the groups for continuous and categorical variables following testing for normality of the data. Mixed model analysis of the primary and secondary outcome variables will be computed to look for differences in group scores across the study time points with treatment type as the between-group and time as the within-subject factor. Concurrent medication use will be included in these analyses as a covariate. We will conduct an exploratory analysis to investigate whether the type of OCD symptoms is related to response to treatment at either site.

We aim to recruit 30 patients into each group (total n=60) allowing for a non-completion rate of 5 subjects per group. Twenty five patients per group will provide an 90% chance of detecting a difference of 5.5 points on the Yale–Brown Obsessive–Compulsive Scale (YBOCS) scale with treatment within each treatment group assuming a standard deviation of 8.0 (2-tailed analysis, p<0.05). If there are differences in efficacy between the groups, this will provide an 80% chance of detecting a difference of 7 points on the Yale–Brown Obsessive–Compulsive Scale (YBOCS) scale between the groups (also assuming a standard deviation of 8.0 (2-tailed analysis, p<0.05)). Given a baseline YBOCS level of around 35 this will mean a 20% difference between the groups in final YBOCS score, which is likely to be of clinical significance.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
14/08/2017
Actual
1/09/2017
Date of last participant enrolment
Anticipated
17/06/2019
Actual
20/12/2018
Date of last data collection
Anticipated
Actual
11/02/2019
Sample size
Target
60
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 8589 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 16696 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 293433 0
Hospital
Name [1] 293433 0
Epworth HealthCare
Country [1] 293433 0
Australia
Primary sponsor type
Hospital
Name
Epworth HealthCare
Address
Epworth Camberwell
888 Toorak Road
Camberwell
VICTORIA 3124
Country
Australia
Secondary sponsor category [1] 292258 0
Other Collaborative groups
Name [1] 292258 0
Monash Alfred Psychiatry Research Centre (MAPrc)
Address [1] 292258 0
Level 4 - 607 St Kilda Road
Melbourne VIC 3004
Country [1] 292258 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294904 0
The Melbourne Clinic Research Ethics Comittee
Ethics committee address [1] 294904 0
130 Church Street
Richmond VIC 3121
Ethics committee country [1] 294904 0
Australia
Date submitted for ethics approval [1] 294904 0
Approval date [1] 294904 0
15/08/2015
Ethics approval number [1] 294904 0
#266
Ethics committee name [2] 298261 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [2] 298261 0
Epworth HealthCare
89 Bridge Road
Richmond VIC 3121
Ethics committee country [2] 298261 0
Australia
Date submitted for ethics approval [2] 298261 0
13/02/2017
Approval date [2] 298261 0
Ethics approval number [2] 298261 0
EH2017-182

Summary
Brief summary
This study is assessing the efficacy of Theta Burst Stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), in treating Obsessive Compulsive Disorder (OCD). It is a randomised control trial where participants will receive bilateral TBS to one of two different brain cortical regions. Each treatment course will involve TBS twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate treatment.

During treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65198 0
Prof Paul Fitzgerald
Address 65198 0
ANU School of Medicine and Psychology, Ground Floor, Florey Building, ANU, 54 Mills Rd, Acton ACT 2601
Country 65198 0
Australia
Phone 65198 0
+61 2 6125 2622
Fax 65198 0
n/a
Email 65198 0
paul.fitzgerald@monash.edu
Contact person for public queries
Name 65199 0
Prof Paul Fitzgerald
Address 65199 0
ANU School of Medicine and Psychology, Ground Floor, Florey Building, ANU, 54 Mills Rd, Acton ACT 2601
Country 65199 0
Australia
Phone 65199 0
+61 2 6125 2622
Fax 65199 0
n/a
Email 65199 0
Paul.fitzgerald@monash.edu
Contact person for scientific queries
Name 65200 0
Prof Paul Fitzgerald
Address 65200 0
ANU School of Medicine and Psychology, Ground Floor, Florey Building, ANU, 54 Mills Rd, Acton ACT 2601
Country 65200 0
Australia
Phone 65200 0
+61 2 6125 2622
Fax 65200 0
n/a
Email 65200 0
paul.fitzgerald@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is insufficient data to be of value on open access repositories


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.