FDA-cleared TMS for depression that has not responded to medication.

How TMS works

A trained technician places an electromagnetic coil against the side of your head, typically over the left dorsolateral prefrontal cortex — a region that regulates mood. Brief magnetic pulses pass painlessly through the skull and induce small electrical currents that gently stimulate the underlying neurons. The treatment is awake, seated, and non-sedating.

Because the magnetic pulses are focused on a specific brain circuit rather than circulating through the body, TMS does not cause the systemic side effects that often come with antidepressant medications — no weight changes, no sexual side effects, no sedation. The most common side effect is mild scalp discomfort or a brief headache after the session, which usually fades over the first week of treatment.

What you feel during a session

Most patients describe the pulses as a tapping or knocking sensation on the scalp. The first session includes a brief mapping step to locate the right stimulation site and find the right intensity for your individual motor threshold. After that, sessions follow the same protocol each weekday.

Who TMS is for

TMS is most often considered for patients with treatment-resistant major depression — adults who have tried one or more antidepressant medications in the current depressive episode without enough improvement. The STAR\*D study, the largest real-world depression-treatment trial in U.S. history, found that about a third of patients reach full remission on their first antidepressant, and the remission rate drops with each successive medication trial.¹ For people who have already moved through several medication trials, TMS opens a different pathway that does not depend on swallowing another pill.

TMS is also FDA-cleared for obsessive-compulsive disorder (OCD). The OCD protocol targets a different brain region (the supplementary motor area or anterior cingulate cortex, depending on the device's clearance) and uses different stimulation parameters than the depression protocol.

You may be a TMS candidate if

• You have moderate-to-severe major depression that has not responded sufficiently to antidepressant medication in the current episode.
• You have OCD and want a non-medication option, or medication has not been enough.
• You cannot tolerate the side effects of antidepressants.
• You prefer a treatment that does not affect the rest of your body.
• You can commit to a daily-weekday treatment schedule for about six weeks.

TMS may not be the right next step if

• You have metal implants near the head (cochlear implants, deep-brain stimulators, aneurysm clips).
• You have a history of seizures or a condition that meaningfully raises seizure risk.
• You have an active substance-use issue that needs to be addressed first.
• The diagnosis itself has not been fully clarified — sometimes a careful re-evaluation comes before any neuromodulation.

We screen for all of these during the initial clinical evaluation and explain clearly what we find.

The device we use and its FDA clearances

MyNeuPath delivers TMS using a system from Brain Ultimate, Inc. Brain Ultimate's repetitive transcranial magnetic stimulation system holds multiple FDA 510(k) clearances. The device is classified as a Class II medical device under 21 CFR §882.5805 (Repetitive Transcranial Magnetic Stimulation system).

What a treatment course looks like in our clinic

The specific protocol Dr. Roumani recommends for you depends on your diagnosis, prior treatment history, and clinical evaluation. [CONFIRM: which Brain Ultimate model and which cleared protocols MyNeuPath delivers — standard MDD, iTBS, OCD, or a combination — and the typical course length the clinic quotes patients.]

What a typical TMS course looks like

1. Clinical evaluation. 45–60 minutes with a psychiatrist or PMHNP to review prior treatment, current symptoms, medical history, and whether TMS makes sense as the next step.
2. Insurance verification. Most major plans cover medically necessary TMS for treatment-resistant depression after documented antidepressant trials. We verify benefits and explain what your out-of-pocket cost will be before scheduling.
3. Mapping session. Your first treatment session includes a brief motor-threshold determination — finding the right stimulation intensity for your individual anatomy.
4. Daily-weekday sessions. Each session is shorter than a typical office visit. You sit in a comfortable treatment chair, awake, while the technician delivers the prescribed pulse sequence.
5. Periodic check-ins. Your prescribing clinician reviews progress at set intervals — typically after the first week, halfway through the course, and at the end.
6. Tapering or maintenance. Many TMS courses include a brief taper of additional sessions over the following weeks. Some patients with recurrent depression benefit from maintenance sessions periodically.

What the evidence says

TMS for major depression has been studied in dozens of controlled trials over more than two decades. Response rates in real-world clinical samples are typically reported in the 40–60% range, with full-remission rates in the 30–40% range — meaningful improvement, but not a guarantee. Patients who have failed multiple prior medication trials tend to have somewhat lower response rates than those failing just one trial, which is why the STAR\*D framing matters: TMS is most useful as a different mechanism, not as a stronger version of medication.

Our reading discipline: every efficacy claim on this page is anchored in either the FDA's 510(k) clearance record (which establishes the device's safety and substantial equivalence to predicate devices) or in published peer-reviewed primary literature. We do not cite manufacturer marketing aggregates. If you want the underlying citations for a specific claim, ask your clinician at the evaluation.