Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000598684
Ethics application status
Approved
Date submitted
30/05/2014
Date registered
5/06/2014
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sequentially applied transcranial magnetic stimulation in the treatment of obsessive compulsive disorder
Scientific title
Do patients with obsessive compulsive disorder (OCD) who receive active, sequentially applied transcranial magnetic stimulation experience reductions in obsessive and compulsive symptoms over and above patients who receive sham stimulation.
Secondary ID [1] 284682 0
Nil
Universal Trial Number (UTN)
U1111-1157-4271
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive compulsive disorder 292022 0
Condition category
Condition code
Mental Health 292368 292368 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with OCD will receive 15 daily sessions (Monday to Friday) of repetitive transcranial magnetic stimulation over three weeks. Repetitive transcranial magnetic stimulation will be administered using a Magstim Rapidstim system with a 70mm, figure of eight air cooled coil applied to three brain regions sequentially. A fitted cap based on the accepted 10-20 electroencephalography system will be used to identify the three brain regions. The cap will be centred using several landmarks including the distance between the left and right ears (inter-aural distance) and between the bridge of the brow and protrusion in the back of the head (nasion to inion). As the cap is pre-marked, we will be stimulating the left orbitofrontal cortex at coordinate Fp1 using low frequency parameters of 1 Hz using 80% of active motor threshold for 10 minutes (600 pulses), the right dorsolateral prefrontal cortex at the coordinate F4 using high frequency parameters of 10hz for 5 seconds, with an inter-train interval of 25 seconds for 10 minutes (20 trains in total) using 110% of resting motor threshold and the supplementary motor area which will be defined as 15% of the distance between the nasion and inion anterior to the centre point using low frequency parameters of 1Hz at 110% of resting motor threshold for 10 minutes. Overall, patients will be required to attend 40 minute sessions which includes treatment administration and set-up.
Intervention code [1] 289469 0
Treatment: Devices
Comparator / control treatment
Sham repetitive transcranial magnetic stimulation will be applied to the left orbitofrontal cortex, the right dorsolateral prefrontal cortex and supplementary motor area sequentially using the same coordinates outlined above. Sham treatment will be administered using a Magstim 70mm, figure of eight, air cooled sham coil that is identical to the look, sound and percussion of the real 70mm coil. However, the sham coil does not have any conducting material and does not induce or stimulate the brain.
Control group
Placebo

Outcomes
Primary outcome [1] 292228 0
Patient symptom severity will be measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS).
Timepoint [1] 292228 0
The YBOCS will be administered at four time points including baseline measures to be taken at the beginning of the trial, at the end of the final session and after one week and one month thereafter.
Secondary outcome [1] 308462 0
Patient negative affective symptoms will be measured using the Depression, Anxiety and Stress Scales (DASS).
Timepoint [1] 308462 0
The DASS will be administered at four time points including baseline measures to be taken at the beginning of the study, at the end of the final session, then after one week and one month thereafter.
Secondary outcome [2] 308481 0
Patient neurocognitive functioning will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Timepoint [2] 308481 0
The CANTAB will be administered at four time points including baseline measures to be taken at the beginning of the trial, at the end of the final session, then after one week and 1 month thereafter.
Secondary outcome [3] 308482 0
Patient verbal fluency will be measured using the Delis-Kaplin Executive Function System (D-KEFS) verbal fluency form.
Timepoint [3] 308482 0
The D-KEFS will be administered at four time points including baseline measures to be taken at the beginning of the trial, at the end of the final session, then after one week and 1 month thereafter.
Secondary outcome [4] 308523 0
Patient Intelligence Quotient will be estimated using the Test of Premorbid Functioning.
Timepoint [4] 308523 0
The Test of Premorbid Functioning will be administered at four time points including baseline measures to be taken at the beginning of the trial, at the end of the final session, then after one week and 1 month thereafter.

Eligibility
Key inclusion criteria
Patients with a primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders IV-Test Revision (2000) criteria.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are to be excluded if they have metal implants in or around the head, implanted pace maker or pace maker like devices, metal clips or shrapnel inside the head, if the patient has a past history of epilepsy/seizures, pregnant females and patients who have concurrent psychotic symptoms.

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)
Allocation concealment will be achieved by having an independent researcher not affiliated with the proposed study generate a random allocation sequence matched to a unique patient identifier (e.g. the patient’s ID code). Allocation to the control or experimental group will involve contacting the independent researcher who is ‘off site’ for a unique patient identifier. As the unique patient identifier will already be generated by the independent researcher, the researchers involved in the actual conduct of the study will not be able to influence patient group allocations. Moreover, researchers involved in the study will not be privy to the generated list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Previous TMS clinical trials in OCD patients have shown that magnetic stimulation induces low to moderate effects. With this assumption, an a priori power analysis using the power analysis program G*power (Faul, Erdfelder, Lang & Buchner, 2007) indicated that in order to detect small effect sizes (0.40), with power (1-beta) set at 0.80 and a = 0.05 (two-tailed), a total of 100 patients in the control and experimental group would be required. The sample size of 30 patients was selected due to the potential difficulty in recruiting from a vulnerable population, the novelty of the protocol, and the resources available to the researchers. As the study is longitudinal in nature and involves comparing two groups, we will submit our data to repeated measures analysis of variance, if statistically appropriate, to determine whether there are group differences between patient symptomology and neurocognitive functioning.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/08/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8208 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 289315 0
University
Name [1] 289315 0
Deakin University
Country [1] 289315 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood VIC, 3125
Country
Australia
Secondary sponsor category [1] 287986 0
None
Name [1] 287986 0
Address [1] 287986 0
Country [1] 287986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291078 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 291078 0
Human Research Ethics Office, Deakin Research Integrity, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125
Ethics committee country [1] 291078 0
Australia
Date submitted for ethics approval [1] 291078 0
30/06/2014
Approval date [1] 291078 0
05/02/2015
Ethics approval number [1] 291078 0
EC00213

Summary
Brief summary
This project aims to evaluate the effectiveness of a brain stimulation technique referred to as transcranial magnetic stimulation (TMS) in treating obsessive compulsive disorder (OCD). Thirty OCD patients will allocated to either the control or experimental condition and receive TMS once daily for three weeks (Monday to Friday). Patients will then be followed up at two times points; after one week and four weeks post-treatment. The treatment protocol will consist of identifying and stimulating three brain regions which have been shown to be involved in OCD. Each region will be stimulated for 10 minutes using TMS parameters developed within well-established safety guidelines. We will measure the primary and secondary symptoms that patients experience and also measure their ability to perform computerised and pen and paper tasks. It is hypothesised that patients who undergo active treatment will experience a reduction in their OCD symptoms when compared to patients in the control condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48762 0
Dr Linda Byrne
Address 48762 0
School of Psychology
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 48762 0
Australia
Phone 48762 0
+61 3 92446424
Fax 48762 0
+61 3 92446858
Email 48762 0
[email protected]
Contact person for public queries
Name 48763 0
Dr Linda Byrne
Address 48763 0
School of Psychology
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 48763 0
Australia
Phone 48763 0
+61 3 92446424
Fax 48763 0
+61 3 92446858
Email 48763 0
[email protected]
Contact person for scientific queries
Name 48764 0
Dr Alan Pearce
Address 48764 0
School of Psychology
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 48764 0
Australia
Phone 48764 0
+61 3 92517224
Fax 48764 0
+61 3 92446858
Email 48764 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
The study has been withdrawn.


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.