Since March 2024, TMS has been FDA-cleared for depression in teenagers and young adults aged 15 to 21, but only as an add-on. The NeuroStar label reads "as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21)," which means alongside an antidepressant and other care, not in place of them. At least six other systems now carry the same 15-to-21 adjunct wording. TMS for depression is not cleared for anyone under 15, and uses for other psychiatric conditions in this age group are off-label.
For parents, the most important thing to know is that the evidence is split. The clearance rests on large open-label registry data that look encouraging, while the one large sham-controlled trial in adolescents found active TMS no better than sham. Both facts belong in your decision.
If you are thinking about suicide or are in crisis, call or text 988 (the 988 Suicide & Crisis Lifeline) or go to the nearest emergency room.
The adolescent clearances at a glance
| System | FDA decision | Ages |
|---|---|---|
| NeuroStar Advanced Therapy | March 2024 (K231926) | 15 to 21, adjunct |
| Magstim Horizon 3.0 | March 2025 (K243869) | 15 to 21, adjunct |
| MagVenture | August 2025 (K251125) | 15 to 21, adjunct |
| Apollo (Mag & More) | September 2025 (K243700) | 15 to 21, adjunct |
| BrainsWay Deep TMS | November 2025 (K251391) | 15 to 21, adjunct |
| Nexstim NBS 6 | March 2026 (K252358) | 15 to 21, adjunct |
| BTL-699 | August 2026 (K260691) | 15 to 21, adjunct |
Source: FDA 510(k) records for each number listed.
You may see the 2024 clearance described as a "first-line add-on." That phrase came from the manufacturer's press release; the FDA indication says "as an adjunct," and "first-line" does not appear in it. TMS devices are "cleared," not "approved"; what FDA clearance means explains the difference.
What "adjunct" means for your family
Adjunct means TMS is added to an existing plan. In practice your teen would usually be taking an antidepressant and seeing a therapist, and TMS would be layered on top. It is not a way to avoid medication, and it is not a replacement for therapy.
This differs from the way adult TMS is often described. The adult depression labels do not use the word adjunct, and the original adult pivotal trial treated people who were not taking antidepressants at the time. For 15-to-21-year-olds, the cleared use assumes ongoing treatment. Before any referral, it is worth making sure the basics have been done well: an adequate dose and duration of medication, real engagement with evidence-based therapy, and attention to sleep, substance use and school stress. These guides on how depression treatment differs for teens and medication management for teens and young adults cover that groundwork.
What the evidence shows, and what it does not
The registry data behind the clearance
FDA cleared the NeuroStar adolescent label on a retrospective analysis of its TrakStar registry: 1,169 patients aged 12 to 21 treated with the standard protocol over 15 years, at 347 centers. In that analysis, 30.0% reached remission on the PHQ-9, a self-report questionnaire, and the average PHQ-9 score fell by 10.0 points. About 45% of adolescents in the registry were left out for insufficient data, and the age floor was set at 15 because only 10 patients were 12 to 14.
BrainsWay's 2025 clearance used similar real-world data on 1,120 patients aged 15 to 21. PHQ-9 remission was 19.3% after 6 weeks and 30% after 36 sessions; response was 54.4% and 66.1% at the same points. A 2025 registry paper compared adolescents with young adults and found similar results in both groups, with about 70% reporting meaningful improvement and fewer than 1% reporting meaningful worsening.
The sham-controlled trial
The only large randomized, sham-controlled trial of standard TMS in adolescents (Croarkin et al., 2021) enrolled 103 people aged 12 to 21 with treatment-resistant depression at 13 sites. TMS was given without added medication for 6 weeks. Response was 41.7% with active TMS and 36.4% with sham, and remission was 29.2% vs 29.0%; neither difference was statistically significant. There were no new safety signals.
How to read the two together
Registry studies have no sham group, depend on self-report, and count only people with complete data, so they tend to look better than controlled trials. The large improvement in the adolescent sham arm shows how much teenagers improve with attention, structure and time alone. The fairest summary is that no new safety signals have appeared in this age group and many teens and young adults improve during a course, but whether TMS itself adds benefit beyond good care has not been shown in a controlled trial. A careful psychiatrist will say that plainly.
Who might be a reasonable candidate
- Aged 15 to 21 with a diagnosis of major depressive disorder.
- Still significantly depressed despite an adequate antidepressant trial and real engagement in therapy.
- Able to continue that treatment during the TMS course.
- Medically screened: no metal in the head, no electronic implants, and a review of seizure history (see TMS and metal implants).
- Willing, not just compliant. A teen who does not want to come will not get much from daily sessions.
TMS is usually not the right step when depression comes with psychosis or acute suicidal thinking. Expert consensus advises that people with psychotic symptoms or acute suicidal ideation be considered for treatments with more established efficacy. Bipolar disorder, eating disorders and substance use also need careful assessment first. For broader warning signs, see signs of depression in adolescents.
Consent and the parent's role
For a minor, a parent or legal guardian generally gives consent for treatment, and good practice also asks for the teen's own agreement after an age-appropriate explanation. For young adults, the patient consents, and parents take part only as the young adult chooses.
Parents can help in concrete ways: attend the consultation, bring a list of past medications with doses and dates, describe changes in mood and behavior at home, and keep an eye out between sessions for agitation, unusual energy, worsening mood or new thoughts of self-harm. Report any of these to the TMS team the same day. The guide to supporting a loved one through TMS has more on the practical side.
Fitting TMS around school
A standard course is daily, five days a week. The NeuroStar course on the label is six weeks of daily sessions followed by a three-week taper, 36 sessions in total. A standard session runs from about 19 to 37.5 minutes of stimulation, depending on settings. Add travel and check-in time, and most families plan around an hour a day.
Tips that help:
- Ask for early-morning or after-school slots, and book the full course before starting.
- Talk to the school counselor about a temporary schedule adjustment if needed; an existing accommodation plan may already cover health appointments.
- Avoid starting right before exams or a long holiday, since missed sessions add up.
- Expect some scalp discomfort or headache early on; it usually fades after the first week.
For college students and young adults with jobs, working, studying and driving during TMS covers schedules in more detail, and what TMS feels like helps a nervous teen know what to expect.
Safety in younger patients
The adolescent trials and registries reported no new safety concerns compared with adults. The main labeled risk at any age is seizure, which is rare: within published guidelines and without risk factors, a large survey found fewer than 1 seizure per 60,000 sessions. The international safety guideline lists sleep deprivation, alcohol use and recreational stimulants among things that lower the seizure threshold, and all three can come up around exams, parties and college life. Be honest with the TMS team about these, and help your teen keep sleep regular during the course. More detail is in TMS side effects.
Questions parents can ask the TMS team
- Which device will you use, and is my child's age within its cleared label?
- Will you treat as an add-on to current medication, as the label specifies?
- Who will be the supervising psychiatrist, and how will you coordinate with my child's therapist and prescriber?
- Which scales will you use to track progress, and how often will you review them with us?
- What is your plan if mood worsens, agitation appears, or nothing has changed by the midpoint?
- How are missed sessions handled during exams or holidays?
Good answers are specific. A team that is comfortable explaining both the registry results and the negative sham-controlled trial is a team that is being straight with you. Ask your teen to come up with a question too; being part of the decision makes a daily commitment easier to keep.
Insurance for minors and young adults
Coverage for adolescent TMS is newer and less predictable than coverage for adults, because the first adolescent clearance came only in 2024 and plans differ in whether their policies have caught up. Ask your plan in writing whether it covers TMS for your teen's age, what it requires (often documented medication and therapy trials), and whether prior authorization is needed. Does insurance cover TMS walks through the questions to ask.
For broader help, see the practice's child and adolescent psychiatry and therapy services. The TMS guide covers the rest of the TMS topics, and the TMS therapy page explains how to start a conversation about whether it fits.
Sources
- Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biological Psychiatry (O'Reardon et al.), 2007. pubmed.ncbi.nlm.nih.gov
- 510(k) K231926 and 510(k) Summary, NeuroStar Advanced Therapy System. U.S. Food and Drug Administration, 2024. accessdata.fda.gov
- 510(k) K251391 and 510(k) Summary, BrainsWay Deep TMS (adolescents). U.S. Food and Drug Administration, 2025. accessdata.fda.gov
- 510(k) K251125, MagVenture TMS Therapy System (adolescents). U.S. Food and Drug Administration, 2025. accessdata.fda.gov
- 510(k) K243869, Magstim Horizon 3.0. U.S. Food and Drug Administration, 2025. accessdata.fda.gov
- 510(k) Premarket Notification database (records for K231926, K243869, K251125, K243700, K251391, K252358, K260691). U.S. Food and Drug Administration, 2026. accessdata.fda.gov
- Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. Neuropsychopharmacology (Croarkin et al.), 2021. pubmed.ncbi.nlm.nih.gov
- The Effectiveness of Transcranial Magnetic Stimulation in Adolescents and Young Adults With Major Depressive Disorder. JAACAP Open (Croarkin et al.), 2025. pubmed.ncbi.nlm.nih.gov
- Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. Journal of Clinical Psychiatry (McClintock et al.), 2018. pmc.ncbi.nlm.nih.gov
- Safety Information. NeuroStar (Neuronetics), 2026. neurostar.com
- Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Clinical Neurophysiology (Lerner et al.), 2019. europepmc.org
- Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clinical Neurophysiology (Rossi et al., IFCN), 2021. europepmc.org
FAQs
What is the youngest age for TMS?
The FDA-cleared adolescent labels start at 15 and run to 21, as an add-on to other treatment. TMS for depression under 15 is off-label.
Does my teen have to stay on antidepressants during TMS?
The adolescent clearance is as an adjunct, meaning alongside existing treatment such as an antidepressant. Any medication change should be planned with the prescribing psychiatrist.
Is TMS safe for a developing brain?
Studies in adolescents have not found new safety signals compared with adults, and serious side effects are rare. Long-term data specific to teenagers are limited, which is worth discussing with the psychiatrist.
Can a 19-year-old in college get TMS without their parents?
Yes. Young adults consent for themselves. Parents can be involved if the young adult wants them to be, which many find helpful for scheduling and support.
Is TMS cleared for teens with ADHD, OCD or anxiety?
No. The adolescent clearances for psychiatric conditions cover major depressive disorder only. Uses for ADHD, OCD or anxiety in this age group are off-label and mostly research-stage.
