OptiTMS trial
Project Details
Major Depression is a leading cause of disability worldwide and often difficult to treat. Transcranial Magnetic Stimulation (TMS) is a promising non-invasive therapy for treatment of difficult to treat depression, but while life-changing for some individuals, others receive little benefit. Emerging research suggests that TMS clinical effects might be related to the precise part of the brain at which TMS is delivered.
Optimised Transcranial Magnetic Stimulation for the Treatment of Depression (OptiTMS) trial aims to compare the clinical benefits of two different methods of TMS treatment delivery. We will compare current TMS treatment where the stimulation target is based on the size of a person’s scalp to a newer approach where the stimulation target is more tailored and specific (optimised) and based on a person’s brain Magnetic Resonance Imaging (MRI) scan image.
The trial will be conducted at three sites in Australia, and it will involve 310 participants, randomised in 1:1 ratio to the standard TMS treatment or the optimised TMS treatment group. Participation in this study will involve completion of 4 weeks of daily TMS treatment (Monday to Friday) and an MRI scan, as well as visits at which clinical interviews and questionnaires will be completed.
The study is led by A/Prof Robin Cash.
What is repetitive TMS (rTMS)?
Repetitive transcranial magnetic stimulation (rTMS) is a gentle, non-invasive treatment that can help with certain mental health conditions. Also known as intermittent theta-burst stimulation, rTMS may be an option for people who haven’t felt better with traditional medication or therapy. At the Department of Psychiatry, we use the latest rTMS technology to support people experiencing treatment-resistant depression.
rTMS works by sending gentle magnetic pulses to targeted parts of the brain that play a role in mood. In each session, a special coil is positioned against the scalp to deliver these pulses, which are painless and safe. The stimulation helps adjust brain activity in those areas, with the goal of improving mood and reducing symptoms linked to mental health conditions.
Benefits of rTMS Treatment
Gentle and non-invasive
rTMS is a safe, non-surgical treatment that doesn’t require hospital stays or anesthesia. Most people find the sessions comfortable, and side effects are usually mild.
Precise targeting
Instead of affecting the whole brain like many medications, rTMS focuses only on the areas linked to mood and mental health symptoms.
Fewer side effects
Because it works locally in the brain, rTMS is often easier to tolerate than medications and may be a good option for people who struggle with medication side effects.
Potential lasting relief
Many people notice meaningful improvement in symptoms of depression and anxiety, and some continue to feel better even after their treatment course has finished.
Works alongside other therapies
rTMS can be combined with counselling, lifestyle strategies, and medication to create a more complete and supportive treatment plan.
Who is a good candidate for rTMS?
rTMS may be a suitable option for people who:
- Are living with treatment-resistant depression where rTMS is recommended
- Have not been able to tolerate antidepressant medications or have experienced troubling side effects
- Are looking for another treatment option to use alongside antidepressant medications
- Are currently under care of a psychiatrist or GP
What is the cost of rTMS treatment?
Medicare Benefits Schedule subsidised rTMS therapy is available for patients over the age of 18 years who have tried at least two classes of antidepressants and remain unwell. It covers patients who have not received rTMS therapy previously. More information can be found through the rTMS Medicare MBS listing.
There are no out of pocket costs associated with participating in the trial.
Interested in our research?
Please read our participant information document for the information regarding the eligibility criteria and commitment required to participate in the trial. Please direct your enquiries to the trial email.
If, after reading the participant information document, you think you might be interested in participating in the OptiTMS trial, please complete our pre-screening survey. Thank you!
Taking part is this study is voluntary. You may withdraw at any time.
OptiTMS trial is registered with the ANZCTR, registration number ACTRN12625000528459
(https://anzctr.org.au/ACTRN12625000528459.aspx).
Researchers
Collaborators
Mental Health and Addition Medicine (SVHM)
Queensland Neurostimulation Centre
Funding
The National Health and Medical Research Council (NHMRC); Application ID: 2032454.
Research Publications
L Hearne, L Webb, R Cash, C Robinson, P Mosley, J Ng, S Thwaites, et. al. Precision TMS in Major Depressive Disorder: An Open-Label Trial of Personalized TMS. Biological Psychiatry 2025, 97(9):S23-S24.
LJ Hearne, L Webb, R Cash, C Robinson, PE Mosley, J Ng, ST Thwaites, et. al. Clinical and Neurophysiological Effects of Robotically-Delivered fMRI-Guided Personalized Transcranial Magnetic Stimulation Therapy for Depression. Psychotherapy and Psychosomatics 2025, 94(4):225–231. doi: 10.1159/000545692
YI Sheline, W Makhoul, AS Batzdorf, FJ Nitchie, KG Lynch, R Cash, et. al. Accelerated intermittent theta-burst stimulation and treatment-refractory bipolar depression: a randomized clinical trial. JAMA psychiatry 2024, 81(9):936-941. doi: 10.1001/jamapsychiatry.2024.1787
RFH Cash, A Zalesky. Personalized and Circuit-Based Transcranial Magnetic Stimulation: Evidence, Controversies, and Opportunities. Biological Psychiatry 2023, 95(6):510-522. doi: 10.1016/j.biopsych.2023.11.013
M Tik, M Woletz, AL Schuler, M Vasileiadi, RFH Cash, A Zalesky, C Lamm, et. al. Acute TMS/fMRI response explains offline TMS network effects–An interleaved TMS-fMRI study. NeuroImage 2023, 267:119833. doi:10.1016/j.neuroimage.2022.119833
RFH Cash, VI Müller, PB Fitzgerald, SB Eickhoff, A Zalesky. Altered brain activity in unipolar depression unveiled using connectomics. Nature Mental Health 2023, 1(3):174-185. doi:10.1038/s44220-023-00038-8
RFH Cash, J Hendrikse, KB Fernando, S Thompson, C Suo, A Fornito, et. al. Personalized brain stimulation of memory networks. Brain Stimulation 2022, 15(5):1300-1304. doi:10.1016/j.brs.2022.09.004
RFH Cash, A Weigand, A Zalesky, SH Siddiqi, J Downar, PB Fitzgerald, et. al. Using brain imaging to improve spatial targeting of transcranial magnetic stimulation for depression. Biological Psychiatry 2021, 90(10):689-700. doi:10.1016/j.biopsych.2020.05.033
RFH Cash, L Cocchi, J Lv, PB Fitzgerald, A Zalesky. Functional magnetic resonance imaging–guided personalization of transcranial magnetic stimulation treatment for depression. JAMA psychiatry 2021, 78(3):337-339. doi:10.1001/jamapsychiatry.2020.3794
RFH Cash, L Cocchi, J Lv, Y Wu, PB Fitzgerald, A Zalesky. Personalized connectivity‐guided DLPFC‐TMS for depression: Advancing computational feasibility, precision and reproducibility. Human brain mapping 2021, 42(13):4155-4172. doi:10.1002/hbm.25330