Indications and Patient Eligibility
NeuroStar TMS has been FDA-cleared for the treatment of Major Depressive Disorder (MDD) in adolescents aged 15 to 21 years, making it the first and only TMS treatment approved for this age group[1][2][5].
Efficacy
Real-world data analyzed through NeuroStar’s TrakStar® platform showed that 78% of adolescents experienced clinically meaningful improvement in depression severity, with notable improvements in mood and quality of life[1][2][3].
Studies have reported a remission rate of up to 44% among adolescents with treatment-resistant depression[4].
Treatment Process
The treatment is non-invasive and non-pharmacological, involving magnetic pulses delivered to the brain areas responsible for mood regulation. Sessions typically last around 19 minutes and are conducted 5 times a week over 4-6 weeks[3][4][5].
Side Effects and Safety
TMS therapy has a favorable side effect profile, with the most common side effects being mild and transient, such as headaches, scalp discomfort, and twitching. There are no negative effects on cognition, and some evidence suggests it may even improve verbal memory[2][4].
Clinical Evidence
The FDA’s decision to grant clearance was based on an analysis of real-world data and clinical literature, which demonstrated that NeuroStar TMS is substantially equivalent in terms of safety and effectiveness compared to antidepressant therapy alone in adolescents[1][2].
Benefits
Offers a promising first-line treatment for adolescents, especially those who have not responded to other treatments. It provides a safe and well-tolerated alternative to traditional antidepressant medications[1][2][5].
Key Points
| Aspect | Details |
|---|---|
| Indication | For MDD in adolescents aged 15-21 years[1][2][5] |
| Efficacy | 78% improvement in depression severity, up to 44% remission rate[1][2][4] |
| Treatment Duration | 4-6 weeks, 5 sessions per week[3][4][5] |
| Side Effects | Mild and transient: headaches, scalp discomfort, twitching[2][4] |
| Safety | No negative effects on cognition, potential improvement in verbal memory[4] |
| Clinical Evidence | Supported by real-world data and clinical literature[1][2] |
| Benefits | Safe, well-tolerated alternative to traditional antidepressants[1][2][5] |
Sources
- FDA Greenlights TMS Therapy for Adolescent Depression - Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences (https://med.uth.edu/psychiatry/2024/04/29/fda-greenlights-tms-therapy-for-adolescent-depression/)
- TMS Therapy for Children and Adolescents - Pros and Cons (https://tmstherapynearme.com/resources/tms-therapy-children-adolescents/)
- FDA Clears NeuroStar TMS for Treatment of MDD in Adolescents (https://www.psychiatrictimes.com/view/fda-clears-neurostar-tms-for-treatment-of-mdd-in-adolescents)
- Adolescent Depression - NeuroStar (https://neurostar.com/adolescent-depression/)
- TMS Therapy (https://nehs.transformationsnetwork.com/tms/)