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NeuroStar® Transcranial Magnetic Stimulation: Solutions for Major Depressive Disorder Beyond Medication
Major Depressive Disorder and Treatment Challenges
In 2020, at least 21 million people in the United States experienced at least 1 episode of major depressive disorder (MDD), a condition involving a depressed mood for at least 2 weeks and accompanied by other symptoms including sleep disturbance and lack of concentration.1-3 Antidepressant medications are the mainstay treatment for MDD; however, it is estimated that more than nearly 7 million people in the United States have tried antidepressants without success.1,4 Seeking MDD remission often involves multiple sequential steps with various treatments. Each subsequent medication attempt can lead to decreased chance of remission (due to treatment resistance) and/or treatment abandonment (due to increased adverse events), according to results from a large prospective clinical trial of MDD, referred to as STAR*D (NCT00021528).1,4
For treatment-resistant MDD, the US Food and Drug Administration (FDA) has cleared transcranial magnetic stimulation (TMS) therapy devices,5,6 such as the NeuroStar® Advanced Therapy System. NeuroStar is the market leader in clinical practice, with more than 5.4 million treatments performed, more than 150,000 patients treated, and more than 15,000 individuals in their patient registry, which has grown to the be largest registry in the world for depression outcomes.7,8
About NeuroStar
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients who suffer from MDD and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.3 NeuroStar is a computerized electromechanical medical device that induces brief pulsed magnetic fields that are focused in local areas of the cerebral cortex via a proprietary “figure-eight” treatment coil.3,9 NeuroStar uses focused magnetic pulses (similar in strength to an MRI), to revitalize underactive areas of the brain involved in regulating mood. When these regions are underactive, depression can result. “Waking up” these regions can have a lasting effect on depression, making long-term remission from depression a reality for many people.3,5,10-12
Efficacy and Safety
NeuroStar has achieved 83% response and 62% remission rates for patients with MDD, according to results from a retrospective study of real-world outcomes in nearly 8000 patients and over 100 sites.5 The NeuroStar® Advanced Therapy Outcomes Registry, which is the largest data set in MDD is comprised of more than 15,000 patients across 118 NeuroStar practice sites.7,8 Outcomes from acute treatment for MDD with NeuroStar are maintained long term, as evidenced by results from another study that demonstrated significant maintenance of response and remission rates through a 12-month follow-up period (P < .0001).11
Treatment with NeuroStar is associated with few adverse effects (AEs) and is generally well tolerated by patients. The most common AE is mild to moderate pain or discomfort at or near the treatment site. AEs typically resolve rapidly; they occur during the TMS treatment course and do not recur for most patients after the first week of treatment.3 While there is a rare risk of seizure associated with the use of TMS therapy (< 0.1% per patient),3 no seizures were reported in NeuroStar prospective clinical trials.
Technology and Resources
NeuroStar is accompanied by technology and resources that support management and ease of use. The NeuroStar® Contact Sensing system ensures that the prescribed dose is delivered to the precise location through real-time feedback in 3 dimensions on the correct treatment coil angle. With this system, patients receive a full treatment without compromised dosage.13 In addition, the TouchStar™ Theta Burst protocol, NeuroStar can deliver higher frequency pulses, which reduces time of treatment sessions to approximately 3 minutes.13,14 The NeuroStar TouchStar™ Theta Burst treatment protocol is substantially shorter than that of the 37.5-minute standard protocol and the 19-minute Dash protocol.
Other NeuroStar technology includes the TrakStar® Patient Data Management System, a proprietary, HIPAA-compliant patient outcomes reporting system; a motor threshold (MT) Cap accessory, which decreases positioning time by 40%; Fast MT™, which enables a simplified MT determination process and reduces the necessary pulses by 50%; and SoftStart™, a technology that introduces a series of stepped pulses within each pulse train that allows for ramping up to the prescribed treatment level.13,14
Providers who use NeuroStar have access to a network of NeuroStar clinical trainers, reimbursement specialists, and a dedicated practice development manager who offer support. Providers also can participate in the NeuroStar 5-STARS to Success program, which supports the growth of a NeuroStar practice through increased patient awareness and access to care.14
Conclusions
Although antidepressants are the mainstay treatment for MDD, millions of Americans do not achieve full symptom relief when taking antidepressant medications.1,4 The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients who suffer from MDD and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.3 The high response and remission rates achieved by NeuroStar, coupled with its advanced technology and available support resources, position the system as a useful non-medication option for the treatment of unresolved symptoms of MDD.5,14
References
1. Qaseem A, Owens DK, Etxeandia-Ikobaltzeta I; Clinical Guidelines Committee of the American College of Physicians, et al. Nonpharmacologic and pharmacologic treatments of adults in the acute phase of major depressive disorder: a living clinical guideline from the American College of Physicians. Ann Intern Med. 2023;176(2):239-252. doi:10.7326/M22-2056
2. Clinical practice guideline for the treatment of depression across three age cohorts. American Psychological Association. February 2019. Accessed April 26, 2023. https://www.apa.org/depression-guideline/guideline.pdf
3. NeuroStar® Advanced Therapy System [Prescribing information]. NeuroStar. Accessed June 29, 2023. https://neurostar.com/wp-content/uploads/NeuroStar-Prescribing-Information.pdf
4. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905-1917. doi:10.1176/ajp.2006.163.11.1905
5. Sackeim HA, Aaronson ST, Carpenter LL, et al. Clinical outcomes in a large registry of patients with major depressive disorder treated with transcranial magnetic stimulation. J Affect Disord. 2020;277:65-74. doi:10.1016/j.jad.2020.08.005
6. O’Reardon JP, Solvason HB, Janicak PG, et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007;62(11):1208-1216. doi:10.1016/j.biopsych.2007.01.018
7. NeuroStar health care provider homepage. NeuroStar. Accessed June 29, 2023. https://neurostar.com/hcp/
8. Why NeuroStar. NeuroStar. Accessed June 29, 2023. https://neurostar.com/hcp/why-neurostar/
9. How does NeuroStar work? NeuroStar. Accessed June 29, 2023. https://neurostar.com/how-does-neurostar-work/
10. Janicak PG, Nahas Z, Lisanby SH, et al. 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 Stimul. 2010;3(4):187-199. doi:10.1016/j.brs.2010.07.003
11. Dunner DL, Aaronson ST, Sackeim HA, et al. A multisite, naturalistic, observational study of transcranial magnetic stimulation for patients with pharmacoresistant major depressive disorder: durability of benefit over a 1-year follow-up period. J Clin Psychiatry. 2014;75(12):1394-1401. doi:10.4088/JCP.13m08977
12. Liston C, Chen AC, Zebley BD, et al. Default mode network mechanisms of transcranial magnetic stimulation in depression. Biol Psychiatry. 2014;76(7):517-526. doi:10.1016/j.biopsych.2014.01.023
13. NeuroStar Technology. NeuroStar. Accessed June 29, 2023. https://neurostar.com/hcp/technology/
14. Data on file at Neuronetics, 2023. NeuroStar product brochure.
