FDA Approves TMS
Treatment for Ages
15-21 With
NeuroStar

The recent FDA approval of NeuroStar® Advanced Therapy for people aged 15-21 marks a significant breakthrough in mental health treatment for our youth. This non-invasive TMS procedure, which uses magnetic fields to stimulate nerve cells in the brain, has already shown promising results in adult populations struggling with treatment-resistant depression. By expanding access to innovative therapy for younger patients, the FDA’s decision opens new doors for adolescents facing mental health challenges during some of life’s most formative and turbulent years.

FDA Approves TMS Treatment for Ages 15-21 With NeuroStar

The recent FDA approval of NeuroStar® Advanced Therapy for people aged 15-21 marks a significant breakthrough in mental health treatment for our youth. This non-invasive TMS procedure, which uses magnetic fields to stimulate nerve cells in the brain, has already shown promising results in adult populations struggling with treatment-resistant depression. By expanding access to innovative therapy for younger patients, the FDA’s decision opens new doors for adolescents facing mental health challenges during some of life’s most formative and turbulent years.

Home » FDA Approves TMS Treatment for Ages 15-21 With NeuroStar

Table Of Contents

The Mental Health Crisis Among Youth

The mental health landscape for adolescents and young adults has deteriorated significantly in recent years, creating what many experts now recognize as a genuine public health emergency. Even before the added stressors of the COVID-19 pandemic, teenagers and young adults were experiencing unprecedented levels of depression, anxiety, and suicidal ideation. This age group faces unique challenges as they navigate identity formation, academic pressures, social media influence, and the transition to independence — all while their brains are still developing critical emotional regulation capabilities.

According to the CDC's Youth Risk Behavior Survey, approximately 40% of high school students reported persistent feelings of sadness or hopelessness in 2023, up from 30% a decade earlier.
The National Institute of Mental Health reports that about 20% of adolescents (ages 12-17) experienced at least one major depressive episode in 2021.
Suicide is the second leading cause of death among individuals aged 10-24.
Less than half of adolescents with depression receive treatment, highlighting significant gaps in care.
The economic burden of adolescent depression extends beyond healthcare costs to include educational impacts, with depressed teens being twice as likely to drop out of high school.

Understanding TMS Treatment

Transcranial magnetic stimulation (TMS) is a groundbreaking approach to treating depression that fundamentally differs from traditional medication and talk therapy. This non-invasive procedure utilizes precisely targeted magnetic pulses to stimulate specific regions of the brain associated with mood regulation, particularly the dorsolateral prefrontal cortex. During a typical session, which lasts approximately 20-40 minutes, patients remain fully awake and alert while a magnetic coil is positioned against their scalp. The coil generates magnetic fields that pass painlessly through the skull and convert to small electrical currents that activate neurons in targeted brain regions, effectively “reawakening” areas that show decreased activity in people with depression.

What makes TMS particularly appealing for younger patients is its minimal side effect profile compared to antidepressant medications — most people report only mild headaches or scalp discomfort at the treatment site. The clinical outcomes have been remarkably promising, with response rates reaching up to 80% and nearly half of patients achieving remission from depressive symptoms. Unlike electroconvulsive therapy, TMS doesn’t require anesthesia and causes no memory loss or cognitive impairment, making it an especially suitable option for adolescents and young adults who are still in formative educational and developmental periods.

What Is Unique About NeuroStar Advanced Therapy System?

NeuroStar Advanced Therapy System is a pioneering breakthrough in the treatment landscape for adolescent depression, distinguished by its status as the first and only TMS treatment to receive FDA clearance for patients aged 15-21. This landmark approval, granted in March 2024, establishes NeuroStar as the definitive leader in expanding non-pharmaceutical interventions to younger populations struggling with major depressive disorder.

What truly sets NeuroStar apart is its proprietary TrakStar® platform, which has meticulously documented real-world outcomes across diverse patient populations, providing compelling evidence of its efficacy in adolescents. The data analysis of 1,169 adolescent patients revealed that an impressive 78% achieved clinically meaningful improvement in depression severity when NeuroStar was used as an adjunctive treatment alongside traditional antidepressants.

Why Did NeuroStar System Receive FDA Approval?

The substantial evidence base gathered through the TrakStar® platform was instrumental in the FDA’s determination that the therapy is both safe and effective for this vulnerable age group, representing a significant advancement in addressing the growing mental health crisis among youth. For parents and clinicians who have long struggled with limited treatment options for adolescents with depression, NeuroStar offers a non-invasive alternative backed by robust clinical data and a dedicated system designed specifically to meet the unique needs of younger patients.

NeuroStar's TMS System Is Used for Adjunct Therapy

NeuroStar’s FDA clearance positions this TMS system as adjunct therapy for adolescents with major depressive disorder, representing a crucial distinction in its clinical application. Adjunct therapy is a treatment used in combination with a primary intervention — in this case, antidepressant medication — to enhance overall effectiveness when the primary treatment alone has not produced sufficient results. This complementary approach allows clinicians to maintain existing medication protocols while adding TMS sessions to boost therapeutic outcomes.

The NeuroStar system delivers precisely targeted magnetic pulses to stimulate underactive brain regions associated with depression, working synergistically with pharmaceutical interventions to address depression through multiple neurological pathways. The FDA’s approval for adjunctive use was driven by studies where adolescents continued their prescribed medications while receiving TMS treatment, with the combined approach demonstrating superior outcomes compared to medication alone. Thus, NeuroStar offers a non-pharmacological complement that doesn’t introduce additional drug interactions or systemic side effects

NeuroStar Expands the Treatment Toolkit for Mental Health Professionals

The FDA approval of the NeuroStar system for adolescents introduces a crucial expansion to the mental health treatment options available to professionals working with young patients. This clearance empowers clinicians to offer a targeted, evidence-based procedure that directly addresses the neurological underpinnings of depression. By incorporating TMS into treatment protocols, mental health providers can now explore non-pharmaceutical approaches that enhance the effectiveness of traditional medications and therapy. This is particularly vital in cases where patients struggle to find relief from depression with conventional treatments alone.

What Are the Benefits for Adolescents and Young People?

The FDA approval of the NeuroStar system for adolescents brings several significant benefits for young patients facing depression. These include:

Targeted Treatment: TMS directly stimulates brain areas involved in mood regulation, offering a precise and effective way to address depression’s root causes.

Targeted Treatment: TMS directly stimulates brain areas involved in mood regulation, offering a precise and effective way to address depression’s root causes.
Non-Invasive Approach: Unlike other treatments like electroconvulsive therapy, TMS does not require anesthesia, making it a less intimidating option for young patients.
Minimized Side Effects: TMS is associated with minimal side effects, primarily mild headaches or scalp discomfort, allowing adolescents to tolerate the treatment more easily than traditional medications.
Improved Response Rates: Clinical data has shown that up to 78% of adolescent patients achieve significant improvement in depression severity, with nearly half achieving remission.
No Cognitive Impact: TMS does not cause memory loss or cognitive impairment, unlike some treatments, which is crucial for adolescents still developing academically and socially.
Complementary to Existing Treatments: TMS can be used alongside antidepressant medications to enhance therapeutic outcomes, providing a well-rounded approach to care.

Addressing Concerns and Limitations

While the NeuroStar system offers significant promise, it is essential to acknowledge some concerns and limitations. One key consideration is that TMS may not work for everyone, and results can vary. Additionally, the treatment requires a series of sessions, which could present some challenges for patients and their families in terms of time and commitment. As with any treatment, access to care may also be a barrier, particularly in areas with limited specialized providers. Although TMS has minimal side effects, some patients may still experience mild discomfort, such as headaches or scalp irritation, which can affect their experience. Mental health professionals must also recognize that while TMS is a valuable tool, it should be integrated into a broader, holistic treatment plan that includes psychotherapy and medication when appropriate, ensuring a comprehensive approach to managing depression.

The Bottom Line

The FDA approval of NeuroStar Advanced Therapy System for adolescents marks a pivotal step forward in the treatment of depression among young people, offering an innovative, non-invasive option for those struggling with treatment-resistant disorders. This breakthrough not only expands the toolkit for mental health professionals but also provides much-needed hope for adolescents and their families, offering a targeted, evidence-based alternative to traditional treatments. While there are certain limitations and considerations, the potential for TMS to improve outcomes and reduce reliance on medications makes it a promising addition. As we continue to address the growing mental health crisis among youth, the approval of NeuroStar represents a critical move toward more effective, accessible, and personalized care for the next generation.