None listed
Conditions
Brief summary
Transcranial magnetic stimulation (rTMS) has been established as a safe, effective and well-tolerated treatment for depression in patients who do not get better with other therapies. Although rTMS is an effective treatment, only about 50% of patients get a substantial clinical response and for some this can take a considerable period of time. Over recent years we have conducted extensive research developing methods to both enhance and accelerate treatment response including helping to develop the use of a novel form of rTMS, intermittent theta burst stimulation (iTBS), which can be applied in a far more efficient manner. The overall objective of this research is to try to maximize the number of patients who respond to treatment and to ensure that these benefits are achieved as quickly and as efficiently as possible. This project aims to optimise the application of TBS therapy by exploring whether enhanced outcomes are achieved with a dual site stimulation protocol (as opposed to the standard TBS treatment protocol which targets one site of the brain only).
Interventions
The proposed study aims to optimise the application of iITBS therapy by exploring whether enhanced outcomes are achieved with a dual site stimulation protocol. This study involves a randomised parallel design study with blinded assessment of treatment outcomes. All iTBS will be applied in triplet burst of 3 pulses at 50Hz repeated at 5Hz in 2 second trains with an eight second into train interval (total of 600 pulses).
Participants will be randomized to one of 3 treatment groups:
1. iTBS appli
The proposed study aims to optimise the application of iITBS therapy by exploring whether enhanced outcomes are achieved with a dual site stimulation protocol. This study involves a randomised parallel design study with blinded assessment of treatment outcomes. All iTBS will be applied in triplet burst of 3 pulses at 50Hz repeated at 5Hz in 2 second trains with an eight second into train interval (total of 600 pulses). Participants will be randomized to one of 3 treatment groups: 1. iTBS applied to the left dorsolateral prefrontal cortex (DLPFC) as localised using the Beam F3 method. 2. iTBS to the DLPFC and at a second, more posterior site, localised using the 5 cm method. 3. iTBS to a singular site on the lateral PFC with the Brainsway H1 coil (providing broad stimulation across the prefrontal cortex). Treatment courses in the trial will consist of daily (Monday-Friday) sessions of iTBS onsite at Monarch Mental Health Group clinics for 7 weeks, totaling 35 sessions of iTBS treatment. iTBS will be administered with a MagVenture Magpro magnetic stimulator or equivalent using a 70mm figure-of-8 or the Brainsway TMS system with H1 coil. Treatment will be delivered by TMS technicians within Monarch Mental Health Group clinics across Victoria, Queensland and New South Wales. Study outcomes will be assessed at baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, end treatment and at 1, 3 and 6 month follow up and will take place via video conference calls and through electronic links to forms, carried out and overseen by research staff. Adherence to the intervention will be monitored through session attendance records.
Sponsors
Australian National University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of major depressive episode (MDE), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder or bipolar affective disorder. 18-85 years of age. Treatment resistant depression at Stage I of the Thase and Rush classification. Hamilton Depression Rating Scale (HAMD) score of >17 (moderate – severe depression). No increase or initiation of new antidepressant therapy in the four weeks prior to screening. Demonstrated capacity to give informed consent.
Exclusion criteria
Inability to provide informed consent Medically unstable patients Concomitant neurological disorder or a history of a seizure disorder. Patients who are pregnant or breastfeeding. Active suicidal intent Any psychotic disorder or current active psychotic symptoms Patients who have intracranial implants deemed unsafe for TMS. Significant difficulties with English communication and comprehension.
Outcome results
None listed