Everything you need to know about TMS in Children and Adolescents: FDA Guidelines, Safety, and Ethical Considerations — how it works, what it costs, and how to find a provider who actually knows what they're doing.
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Transcranial magnetic stimulation is an established treatment for several psychiatric and neurological conditions in adults, leading naturally to the question of whether the same benefits can be extended to children and adolescents. Pediatric populations represent a significant unmet need: major depressive disorder, OCD, and anxiety disorders frequently begin in childhood and adolescence, and the available treatment options — including medications with limited safety data in minors and psychotherapy that some children cannot or will not engage with — are inadequate for a substantial proportion of young patients. However, applying TMS to children and adolescents raises unique scientific, regulatory, ethical, and safety questions that deserve careful examination.
What You’ll Learn
- What the FDA has cleared for TMS by condition and age
- What the safety profile looks like for children and adolescents
- What the research shows about TMS for adolescent depression and pediatric OCD
- Important ethical considerations including informed assent
- What parents should know before pursuing TMS for their child
FDA Status and Age Restrictions
FDA clearances for TMS are specific to the device, the condition, and the age group:
For major depressive disorder (MDD): Most TMS devices are cleared for adults age 18 and older. In March 2024, the FDA cleared NeuroStar Advanced Therapy as an adjunct (add-on to antidepressant medication) for adolescents ages 15 to 21 with MDD. It was the first TMS device cleared for this age group, and the clearance was based in part on real-world registry data rather than a conventional randomized trial (MedTech Dive). Other TMS systems remain cleared for adults only.
For OCD: BrainsWay Deep TMS is FDA-cleared (2018) for adults with OCD. It is not cleared for minors.
For migraine: The Spring TMS single-pulse device is FDA-cleared for the acute and prophylactic treatment of migraine in adolescents age 12 and older and adults (2019 clearance).
For smoking cessation: FDA clearance applies to adults.
It is important to note that FDA clearance defines the conditions under which a device has been demonstrated to be safe and effective for its intended use. It does not prohibit off-label use entirely — physicians may prescribe FDA-cleared devices off-label based on their clinical judgment. However, off-label use of TMS in children and in adolescents outside a cleared indication is a significant clinical and ethical decision that should only be made by specialists experienced in both pediatric neuromodulation and the condition being treated.
The Safety Profile in Children and Adolescents
TMS safety in pediatric populations is an active area of research, and the existing safety data are generally reassuring — but not as extensive as the adult data.
Seizure risk: The most serious potential adverse effect of TMS is the induction of a seizure. In adults, seizures are rare with standard protocols and appropriate screening. Pediatric data are more limited, and clinicians screen carefully (excluding patients with epilepsy, structural brain lesions, or other seizure risk factors) and use conservative dosing. Ask any clinic about its screening process and about seizure reports in the population they treat.
Scalp discomfort and headache: These are the most common side effects in pediatric TMS and are similar in frequency and severity to what is observed in adults.
Hearing: The magnetic pulses produced by TMS generate a loud clicking sound. While brief exposure is considered safe, there is a theoretical concern about cumulative auditory risk, and ear protection is used during TMS sessions.
Cognitive and developmental effects: Studies to date have not shown clear cognitive harms, but the long-term developmental implications of repeatedly modulating neural circuits during childhood and adolescence are not yet fully understood.
Published pediatric studies have generally reported TMS to be well tolerated, with scalp discomfort and headache the most common side effects, but sample sizes are small and follow-up is limited.
What the Research Shows in Minors
For adolescent depression: Research includes small controlled and open-label studies and a larger body of real-world data. The 2024 NeuroStar clearance for ages 15-21 was supported by registry data from adolescents treated in clinical practice, which the company reported showed clinically meaningful improvement in most patients. Real-world registry data have limits: there is no sham control, so improvement cannot be attributed to TMS alone.
For pediatric OCD: TMS has been studied in small trials, but it is not FDA-cleared for minors with OCD and the evidence is preliminary.
For pediatric anxiety and ADHD: Studies are small and preliminary, and TMS is not cleared for these conditions.
Ethical Considerations
Treating children and adolescents with TMS raises important ethical questions that clinicians and parents must carefully consider:
Informed assent: Children and adolescents should be involved in the treatment decision to the extent developmentally appropriate. This means explaining the treatment in age-appropriate terms, answering their questions honestly, and respecting their preferences. “Informed assent” — the child’s agreement to treatment — should be obtained alongside parental informed consent.
Long-term unknowns: The developing brain is in a state of active neuroplasticity. While TMS may theoretically enhance positive neuroplastic changes, the long-term effects of repeatedly modulating developing neural circuits are not yet known. This uncertainty should be transparently communicated to parents.
Limited alternatives: The ethical case for considering TMS in minors is strongest when the condition is severe, treatment-resistant, and significantly impairing — and when established alternatives (medications and psychotherapy) have been tried and found inadequate.
Vulnerability to marketing: Parents of children with serious psychiatric conditions are understandably desperate for effective treatments. The enthusiasm of some providers and the desperation of some families must not override careful scientific and ethical evaluation.
What Parents Should Know
For parents considering TMS for their child:
- Start with established treatments first: CBT/ERP and FDA-approved medications (as prescribed by your child’s doctor) for your child’s specific condition should be the first-line approach.
- Seek experienced specialists: TMS for children and adolescents should only be provided by clinicians with specific training and experience in pediatric neuromodulation.
- Understand the regulatory status: One TMS device (NeuroStar, as an adjunct to medication) is FDA-cleared for depression in ages 15 and older. Other uses in minors are off-label. Ask the clinic which device it uses and whether the use is on-label.
- Look for clinical trials: Clinical trials provide access to TMS under carefully controlled research conditions, with close monitoring and institutional review board oversight.
- Get multiple opinions: Before proceeding with any treatment for your child, especially an off-label one, consult with multiple qualified specialists.
The field of pediatric TMS is still developing. For now, TMS for minors should be approached carefully, in specialized settings, with a clear understanding of what is and is not FDA-cleared.
Frequently Asked Questions
At what age can children receive TMS?
Most TMS devices are cleared only for adults. In March 2024 the FDA cleared NeuroStar as an adjunct for adolescents ages 15-21 with major depressive disorder, and the Spring TMS single-pulse migraine device is cleared for ages 12 and older. Other uses in minors are off-label, and research protocols in younger children should include extra safety monitoring and IRB oversight.
Is TMS safe for children and adolescents?
Published pediatric studies have generally reported TMS to be well tolerated, with scalp discomfort and headache the most common side effects, but sample sizes are small and follow-up is limited. Clinics screen carefully for seizure risk.
What conditions in minors has TMS shown benefit for?
The 2024 FDA clearance for ages 15-21 was supported in part by real-world registry data, which lacks a sham control. Evidence in younger children and for pediatric OCD, anxiety, and ADHD is preliminary, and TMS is not cleared for those uses.
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