None listed
Conditions
Brief summary
Obsessive-compulsive disorder (OCD) is a severe mental illness that can dramatically reduce quality of life. Despite use of best practise clinical management, many patients continue to experience symptoms and associated disability. Recent neuroimaging studies have shown that OCD is characterised by significant, yet specific, changes in the activity of macroscopic brain networks comprising of frontal and subcortical brain regions. Parallel to these developments, non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS) have emerged as viable tools to modulate the activity of brain networks in both healthy and pathological populations. TMS has an established clinical role in the treatment of major depressive disorder. This project aims to assess the possible use of local TMS to selectively restore altered brain network activity and improve symptoms in people with OCD. To achieve this goal outpatient with OCD will be asked to undertake functional magnetic resonance imaging (fMRI) before and after a TMS intervention. If successful, the proposed project will represent the first demonstration that TMS can be used to selectively restore the altered function of widespread neural networks and improve symptoms in people diagnosed with OCD. Such an outcome will be instrumental to motivate larger clinical trials to test the efficiency of TMS as a treatment, or complementary treatment, for OCD.
Interventions
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 wil
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.
Sponsors
QIMR Berghofer Medical Research Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
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?
Outcome results
None listed