None listed
Conditions
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 given pathway, a diagnosis of OCD is associated with changes in all major fronto-striatal networks. Non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS) are gaining acceptance as safe and potentially effective treatments for patients with OCD by altering network dysfunction. With current treatment approaches, the choice of which frontal brain regions to be stimulated by TMS is largely decided using trial-and-error. These shortfalls limit the efficacy and reliability of proposed TMS interventions. A way to bypass the arbitrary choice of the frontal cortical region to target using TMS is to stimulate all frontal regions encompassing the three main fronto-striatal pathways affected in OCD. Thus, simultaneous stimulation of the three cortical regions, each belonging to a main fronto-striatal pathway, should result in reduced response variability and better efficacy of TMS in alleviating the severity of OCD symptoms. The proposed study combines behavioural analyses, neuroimaging, and TMS to test this hypothesis.
Interventions
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
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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 measure as part of the clinical assessments. If you have not completed the Y-BOCS with the patient but they have moderate to severe OCD symptoms, please circle N/A. 4. Has the patient had a diagnosis of OCD for a period greater than 12 months? 5. Does the patient have the capacity to give informed consent to participate in the clinical trial? 6. Will the patient be able to attend the Epworth Centre for Innovation in Mental Health (Mon-Fri) for 3 weeks?
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 have Tourette’s syndrome? 8. Has the patient ever suffered from a substance abuse disorder or alcohol/drug misuse? 9. Is the participant pregnant or planning to become pregnant during the duration of the trial?
Outcome results
None listed