Optimised Transcranial Magnetic Stimulation (TMS) for Obsessive Compulsive Disorder (OCD)
Monash UniversityDataset description
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.Identifiers
Source Study
Trial name (public)
Optimised Transcranial Magnetic Stimulation (TMS) for Obsessive Compulsive Disorder (OCD)Trial acronym
OTMSOCD
Trial ID
ACTRN12619000008123
Purpose
Treatment
Phase
Not Applicable
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Dr Luca Cocchi
Brief Summary
Obsessive-Compulsive Disorder (OCD) is a severe mental illness that affects 1-2% of the Australian population (Crino, Slade, & Andrews, 2005). There is currently no cure for OCD and current interventions are not effective to relieve symptoms in many people. The disorder is characterised by marked symptom heterogeneity that map onto distinct alterations in fronto-striatal brain networks activity (Harrison et al., 2013). While specific OCD symptoms are likely to correlate more strongly with a give .... Read more
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 .... Read more
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 .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 49
Min. age 18 Years
Max. age 65 Years
Sex Both males and females
Condition category Obsessive Compulsive Disorder
Condition code Mental Health
Intervention
Intervention code Treatment: Devices
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 (SM .... Read more
Comparison
Control group Placebo
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 .... Read more
Outcomes
Outcome: Difference in Yale and Brown Obsessive Compulsive Scale (Y-BOCS) score Timepoint: Baseline and end of treatment
Outcome: Differences in fronto-striatal functional connectivity as assessed by fMRI Timepoint: Baseline and end of treatment
Will individual participant data (IPD) for this trial be available?
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?
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.