FDA clearance of the NeuroStar TMS Therapy® System was largely based on results of a registration clinical trial program that included the largest multicenter, randomized, controlled trial of TMS in major depression.1,2
A second, similarly designed National Institute of Mental Health (NIMH) sponsored randomized study was published in 2010, and provided additional evidence of TMS efficacy using the clinically significant outcome of remission.3 Other recent studies include an open-label follow on study that replicated the results of Neuronetics’ open-label extension study3, and Neuronetics’ 6-month study of TMS safety and durability.4
Ongoing Clinical Trials
Neuronetics continues to support clinical trial programs. The following are sponsored by Neuronetics:
- Treatment Utilization and Outcomes – This study consists of an acute treatment phase and a one year follow-up of enrolled patients. The study enrollment has closed but the follow up phase of previously enrolled patients continues.
- Maintenance of Effect – This pilot study will evaluate post-acute treatment success and whether or not a monthly maintenance treatment with NeuroStar TMS will decrease the time to re-introduction of another acute course of treatment. This study is currently enrolling patients.
To learn more about clinical trials or search for other TMS studies, please visit clinicaltrials.gov
Other studies using NeuroStar®/Neuronetics devices
Neuronetics does support additional clinical trial programs designed, sponsored and conducted by investigators. Please contact Neuronetics Customer Service at 1-877-600-7555 if you are interested in conducting an Investigator Initiated Trial.
- O’Reardon, J. P., H. B. Solvason, et al. (2007). “Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial.” Biol Psychiatry 62(11): 1208-1216.
- George, M. S., S. H. Lisanby, et al. (2010). “Daily Left Prefrontal Transcranial Magnetic Stimulation Therapy for Major Depressive Disorder A Sham-Controlled Randomized Trial.” Arch Gen Psychiatry. 67(5): 507 – 516.
- Janicak, P. G., Z. Nahas, et al. (2010). “Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month,multisite, open-label study.” Brain Stimulation 3(4): 187-199.