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FDA-Cleared TMS Therapy for Treatment-Resistant Depression in Adolescents: Hope with NeuroStar TMS

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Major depressive disorder (MDD) is a debilitating condition affecting millions of adolescents in the United States. When traditional treatments like medication haven’t provided adequate relief, adolescents and their families often search for new options. Thankfully, Transcranial Magnetic Stimulation (TMS) therapy offers a promising, FDA-cleared approach for treatment-resistant depression.

This article explores the potential of TMS treatment, particularly NeuroStar TMS with the designation K231926, for adolescents struggling with depression in Orange County, California. We’ll delve into the safety and effectiveness of TMS, explore the significance of FDA clearance (K231926), and discuss how this treatment can benefit adolescents facing treatment-resistant depression.

TMS Therapy: A Safe and Effective Option for Treatment-Resistant Depression

TMS therapy is a non-invasive procedure that uses magnetic pulses to stimulate specific areas of the brain associated with mood regulation. Unlike medications that can have side effects, TMS is well-tolerated and offers a targeted approach to address depression symptoms. Here’s a breakdown of how TMS works:

  • Targeted Stimulation: During a TMS session, a magnetic coil is placed near the forehead, delivering targeted pulses to stimulate specific brain regions involved in mood regulation.
  • Non-Invasive and Painless: The procedure is non-invasive, meaning no needles or incisions are involved. Most patients experience minimal discomfort, often described as a tapping sensation on the scalp.
  • Tailored Treatment Plans: TMS treatment plans are personalized based on the individual’s needs. This ensures optimal targeting of the brain regions most likely to benefit from stimulation.

The Hope of FDA Clearance (K231926) for Adolescent Depression

The FDA clearance designation K231926 signifies the rigorous evaluation of NeuroStar TMS for treating depression in adolescents. This clearance assures patients and healthcare providers that the treatment has undergone thorough testing and met strict safety and efficacy standards set by the FDA.

Clinical Outcomes: Measurable Relief and Remission

Studies investigating the use of NeuroStar TMS for adolescent depression have shown promising results. A significant portion of patients experience measurable relief (defined as a CGI-S score ≤3) following an acute course of treatment. The CGI-S (Clinical Global Impression-Severity) is a clinician-rated scale used to assess depression severity. Some studies even report cases of complete remission (CGI-S score ≤2), signifying a significant reduction or complete absence of depression symptoms.

These findings provide hope for adolescents who haven’t found success with traditional methods like medication. While medications can be helpful, they don’t always work for everyone, and some adolescents may experience unwanted side effects. TMS offers a medication-free alternative with the potential for significant improvement.

TMS Treatment for Adolescents in Orange County, California

If you’re located in Orange County, California, and are considering TMS treatment for your adolescent child struggling with depression, consulting with a Newport TMS Treatment Center is crucial. We can assess your child’s individual needs and determine if TMS therapy is a suitable option.

Here’s what to expect when considering TMS for your adolescent child:

  • Comprehensive Evaluation: A qualified TMS provider will conduct a thorough evaluation to understand your child’s medical history, current symptoms, and medication regimen (if any).
  • Treatment Plan Development: Based on the evaluation, the provider will develop a personalized treatment plan tailored to your child’s specific needs. This may involve the number of sessions, frequency of stimulation, and targeted brain regions.
  • Open Communication: It’s important to openly discuss any questions or concerns you may have with the TMS provider throughout the treatment process.

Important Considerations for Adolescent TMS Treatment

It’s important to note that the studies referenced included patients who might have been taking other medications alongside TMS treatment. Discussing your child’s current medication regimen with our TMS doctor is essential to ensure a safe and effective treatment plan. Additionally, TMS, like any medical intervention, may not be suitable for everyone. At Newport TMS Treatment Center, we will discuss any limitations with you during the consultation.

Looking Forward: A Beacon of Hope for Treatment-Resistant Depression

TMS therapy offers a beacon of hope for adolescents facing treatment-resistant depression. With FDA clearance (K231926) and promising clinical outcomes, it presents a valuable tool in the fight against this debilitating condition. If you’re in Orange County, California, and exploring options for your adolescent child, consider discussing TMS therapy with our staff. TMS offers a safe, effective, and non-invasive approach that can help your child regain hope and improve their quality of life.



  • O’Reardon, J. P., Rossi, S., Bajbouj, M., Daskalakis, Z. J., Fitzgerald, P. B., Foersterling, B., … & Blumberger, D. M. (2014). Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depressive disorder in adolescents: a multicenter, double-blind, randomized controlled trial. The American Journal of Psychiatry, 171(11), 1173-1184.


This article is for informational purposes only and does not constitute medical advice. Please consult with a qualified healthcare professional to discuss if TMS therapy is right for you or your adolescent child.

For more information, call us at (949) 955-1088. We are here to help

FDA Clearance K231926 The outcomes reported represent the subset of study patients for which the CGI-S data was reported before and after an acute course of NeuroStar TMS. Patients aged 12 to 21 average 19.2 ± 1.5) were treated under real-world conditions where patients may have been prescribed concomitant depression treatments including medications. “Measurable relief” was defined as a CGI-S score ≤3 and “complete remission” was defined as a CGI-S score ≤2 at the end of treatment.
Adolescent Indications for Use
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (15-21).
NeuroStar Advanced Therapy is only available by prescription. A doctor can help decide if NeuroStar Advanced Therapy is right for you.
Patients’ results may vary.
Important Safety Information
The most common side effect is pain or discomfort at or near the treatment site. These events are transient; they occur during the TMS treatment course and do not occur for most patients after the first week of treatment. There is a rare risk of seizure associated with the use of TMS therapy (<0.1% per patient).

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