Transcranial magnetic stimulation: a working reference for referring clinicians

Overview

TMS is a non-invasive cortical stimulation technique with clear FDA indications, real-world response and remission data, and a rapidly evolving protocol landscape. The useful questions for a referring clinician are usually practical: what protocols are available, what the evidence is for a given indication, and what the contraindications look like.

How we got here

TMS moved from a laboratory curiosity to an FDA-cleared treatment inside a single professional lifetime. Each major leap came from a circuit-level insight about brain networks — not from a chemistry insight. That pattern continues to shape where the field is going.

• 1985Barker
  Anthony Barker and colleagues at the University of Sheffield demonstrate the first TMS-evoked motor response in humans. A magnetic pulse over motor cortex produces a contralateral hand twitch — non-invasive, painless, and reproducible. The essential ingredients for clinical translation are in place.
• 1990sDrevets, George
  PET imaging reveals metabolic abnormalities in the subgenual anterior cingulate cortex (Brodmann area 25) in depression. At the NIH and later at MUSC, Mark George conducts the first human trials targeting left prefrontal cortex with TMS for depression — pointing to a circuit-based framework rather than a neurotransmitter-based one.
• 2005Mayberg
  Helen Mayberg's work reconceptualizes depression as dysfunction of a distributed network, with sgACC as a pathologic hub. Deep brain stimulation of sgACC produces sustained remission in some patients with otherwise-intractable depression (Mayberg 2005). The network framing redirects attention from “chemical imbalance” toward circuit dysfunction.
• 2007–2010OPT-TMS, FDA
  O'Reardon 2007 and George 2010 (OPT-TMS) establish TMS efficacy in pivotal sham-controlled trials. The FDA clears TMS for MDD in adults in October 2008 (NeuroStar). TMS enters clinical practice as an FDA-cleared treatment for treatment-resistant depression.
• 2012Fox
  Michael Fox and colleagues demonstrate that TMS efficacy tracks the degree of functional anticorrelation between the DLPFC stimulation site and the sgACC (Fox 2012). This is the conceptual foundation for fMRI-guided personalized targeting — different individuals have the right target in different cortical locations.
• 2018Blumberger
  The THREE-D randomized non-inferiority trial (n=414) shows that intermittent theta burst stimulation (iTBS, ~3 minutes) is non-inferior to standard 10 Hz rTMS (~37 minutes) in treatment-resistant depression (Blumberger 2018, Lancet). Shorter sessions dramatically expand clinic throughput without compromising outcomes.
• 2022Cole
  Stanford Neuromodulation Therapy (SAINT/SNT) combines accelerated iTBS with fMRI-guided individualized targeting and shows ~79% remission in a randomized sham-controlled trial (Cole 2022). FDA-cleared under K213481. Notably, SAINT's lead investigators (Williams and Bentzley) trained at MUSC under Mark George and Baron Short — continuing a regional research lineage.
• 2024–2025Adolescent clearances
  NeuroStar (March 2024), MagVenture (August 2025), and BrainsWay (November 2025) each receive FDA clearance for adolescent MDD in the 15–21 age range — the first major expansion of TMS indications in a vulnerable population that has few well-tolerated alternatives.

Protocols

Protocols differ in frequency, burst pattern, laterality, session duration, and therapeutic intent. Most share the same underlying logic; they differ in how stimulation is packaged and delivered.

Coil types

Coil geometry determines the field's focality and depth — two properties that trade off against each other. A more focal coil targets cortex precisely but doesn't reach deep structures; a less focal coil reaches deeper but stimulates a larger volume. No single coil is “better” — each is a deliberate choice in that tradeoff (Deng 2016).

The rhythms, visualized

Protocol names proliferate; the underlying differences are mostly about how stimulation is packaged in time. The figures below show a few seconds of each protocol’s pulse structure at a consistent scale. They are schematic, not to clinical scale, but make the differences between protocols immediately visible.

Accelerated schedule: SAINT

Four protocols, one principle

The proliferation of names can obscure what’s actually varying. Across rTMS, iTBS, dTMS, and accelerated protocols, the underlying logic is the same: repeated, targeted stimulation of a cortical node in a dysfunctional network, summed over a course, to produce downstream circuit-level change. What changes between protocols is dose packaging — pulse shape, burst structure, session length, coil geometry, and schedule.

Typical course and taper

A standard clinical course of conventional rTMS or iTBS runs 5 days per week for 6 weeks (30 sessions), followed by a 6-session taper spread over the following 3 weeks for a total of 36 sessions. The bulk of the treatment burden is in the first 6 weeks; the taper is designed to support consolidation of response. Accelerated protocols compress this entire course into 5 days.

Devices

FDA has cleared multiple manufacturers' TMS systems for depression, with newer indications added over time. Devices differ in coil design, session length options, navigation capability, and business model. None is categorically “best” — the right choice depends on the protocols you plan to run and the indications you want to treat.

Some common TMS devices

Specialized / newer platforms

A handful of systems occupy specific niches beyond these:

• Magnus Medical (SAINT/SNT) — licenses the SAINT protocol and uses MagVenture hardware combined with Soterix/Brain Science Tools neuronavigation. Monopoly position on FDA-cleared accelerated fMRI-guided iTBS. Costs are substantially higher than conventional TMS; typically not covered by insurance.
• Nexstim NBT — Finnish system originally designed for pre-surgical mapping, with SmartFocus MRI-based neuronavigation. FDA-cleared for MDD.
• Apollo (MAG & More) — German system using the HANS head-and-neck positioning approach. FDA-cleared for MDD.
• Soterix / Neurosoft — US-bundled system that pairs the Neurosoft stimulator with Soterix's own neuronavigation that does not require line-of-sight.

Choosing a device: what actually matters

Disclosure

The Prisma Health Neuromodulation Program (Brownell Center, Greenville, SC) currently uses NeuroStar, with Magstim and BrainsWay platforms being added. This expansion broadens the protocol options available locally — notably adding BrainsWay's H-coil deep TMS and Magstim's additional protocol options. This page is independent of any manufacturer and is not endorsed by or affiliated with any TMS device company.

Targeting

Where the coil goes matters. Depression outcomes have been shown to vary meaningfully with targeting precision, and targeting has been one of the most active areas of TMS development in the past decade.

Motor threshold (MT)

Stimulation intensity is individualized to each patient's resting motor threshold — the minimum intensity over M1 that reliably produces a contralateral hand muscle response. Treatment doses (commonly 100–120% MT for prefrontal protocols) are scaled from that reference.

Targeting methods, from simplest to most precise

Targeting error adds up. Work from the Brainstim / Acacia group and others has shown that scalp-based methods can miss the intended DLPFC target by ~30 mm on average, and that more precise, connectivity-based targeting improves remission rates in head-to-head comparisons (Cash 2021; Li 2020; Hadas 2019).

Brain networks

Understanding why L-DLPFC is the standard depression target requires stepping back from the coil and thinking about circuits. Depression is increasingly conceptualized as a disorder of large-scale brain networks rather than a single region or neurotransmitter — and TMS works by modulating a specific node within those networks.

Three canonical large-scale networks are implicated in depression, and their interaction is thought to be where the pathology lives:

This framework explains several clinical observations: why precision matters (Cash 2021 — scalp-based targeting misses the individual optimal DLPFC site by ~30 mm on average), why individualized fMRI-guided targeting improves outcomes (the DLPFC locus most anticorrelated with sgACC varies substantially between individuals), and why response prediction may become possible (baseline network connectivity patterns may identify who will respond to which protocol).

Evidence by indication

Evidence strength varies substantially by indication, and — importantly — does not always track with FDA clearance. Data below reflects meta-analyses and large real-world registries where available.

Major depressive disorder

Largest evidence base in the field. Multiple RCTs, meta-analyses, and a large real-world registry (NeuroStar, n=5,010) support both high-frequency left-sided and iTBS protocols for MDD. Key numbers worth knowing:

Durability

Two key studies on how long response lasts:

• Dunner 2014 — Multisite naturalistic observational study of 257 patients with pharmacoresistant MDD. 53% met response or remission criteria after the acute series. Among initial responders, 62.5% continued to meet response criteria throughout 12-month follow-up. ~36% of patients received some form of reintroduction TMS during follow-up.
• Senova 2019 — Systematic review and meta-analysis of depression outcomes at 3, 6, and 12 months after a TMS course. Among initial responders, sustained response rates were 66.5% at 3 months, 52.9% at 6 months, and 46.3% at 12 months. The authors concluded that “maintenance treatment may enhance the durability of antidepressant effects of rTMS and should be considered in clinical practice.”

Meta-analytic effect size

Schutter 2010 meta-analysis of double-blind sham-controlled studies found an overall weighted mean effect size of d = 0.39 (95% CI 0.25–0.54, p<0.0001) for high-frequency rTMS over left DLPFC — comparable in magnitude to antidepressant medications. Vida 2023 reported a risk ratio of 2.25 for response and 2.78 for remission with rTMS as add-on vs. standard pharmacotherapy in patients with two prior treatment failures (19 RCTs, 854 patients).

Low-frequency right-sided: a viable alternative

Low-frequency right-sided rTMS performs comparably to high-frequency left-sided treatment, with a possible advantage in side-effect profile and seizure risk:

• Berlim 2013 — Meta-analysis of 8 RCTs (n=263). Low-frequency right-sided rTMS: 34.6% remission (vs. 9.7% sham; OR 3.35) and 38.2% response (vs. 15.1%; OR 4.76). Conclusion: “LF-rTMS is a promising treatment for MD, with clinically meaningful benefits comparable to standard antidepressants and HF-rTMS.”
• Chen 2013 — Meta-analysis directly comparing HF-left vs LF-right rTMS. No significant difference in efficacy (OR 1.15; 95% CI 0.65–2.03). Authors noted LF right-sided rTMS “produces fewer side effects and is more protective against seizures.”

iTBS vs. conventional rTMS

Bulteau 2022 (THETA-DEP) directly compared iTBS to 10 Hz rTMS in treatment-resistant unipolar depression. Response rates were 36.7% (iTBS) vs. 33.3% (10 Hz rTMS); remission rates were 18.5% vs. 14.8%. The conclusion: iTBS is as effective as rTMS and “probably more cost-effective” — a major reason iTBS has become a workhorse protocol.

Obsessive–compulsive disorder

FDA-cleared in 2018 for deep TMS with H-coil targeting mPFC/ACC. The pivotal trial and subsequent data:

• Carmi 2019 — Multi-center, randomized, double-blind, sham-controlled trial of dTMS for OCD. 29 sessions over 6 weeks. Active treatment: 20 Hz dTMS at 100% MT, 50 trains of 2-second pulse trains with 20-second intervals, totaling 2,000 pulses per session. Mean Y-BOCS change: −6.0 points active vs. −3.3 sham (effect size 0.69). Response rate: 45.2% active vs. 17.8% sham.
• Gersner 2019 — Pooled multicenter + open-label data (n=68). Mean Y-BOCS reduction of 8.6 points (30.1%) through week 6. 60.3% partial response (≥20% Y-BOCS decrease); 47.1% full response (≥30% decrease).

Smoking cessation

FDA-cleared in 2020. Deep TMS approach targeting bilateral insula and prefrontal cortex. Useful alternative for patients who have failed pharmacotherapy and behavioral approaches.

MDD with anxious distress / anxiety

FDA-cleared in 2021–22 for MDD with comorbid anxious distress (not a standalone anxiety indication).

Cox 2022 — Systematic review and meta-analysis of rTMS for GAD and panic disorder (13 studies, 677 patients). In GAD patients with or without comorbidities, rTMS produced significant improvements in anxiety (SMD 1.45; p<0.001) and depression scores (SMD 1.65; p<0.001) regardless of rTMS parameters. For panic disorder, overall severity improvement did not reach statistical significance. Authors conclude rTMS is “a safe and effective treatment for improving anxiety scores in GAD.”

Off-label and emerging indications

TMS has been studied in multiple conditions beyond its FDA-cleared indications. Evidence quality varies widely, and for most of these indications the literature consists of small trials, heterogeneous protocols, and meta-analyses with significant methodological limitations. The table below summarizes what the strongest available meta-analyses show, with notes on the limitations that matter clinically.

How to read this table. Effect sizes reported here come from published meta-analyses, not from individual trials. They are not directly comparable to the response/remission rates quoted for MDD because the underlying studies use different outcome measures and report statistics differently. For off-label use, “there is a signal” is a more accurate characterization than specific response-rate numbers. Rigorous head-to-head RCTs specifically designed for each of these indications — rather than secondary analyses of depression trials — remain the research priority.

FDA clearance history

How TMS works — mechanism

The exact mechanism by which TMS alleviates depression remains incompletely understood. Current evidence suggests it restores aberrantly functioning neurocircuits rather than producing a single-pathway pharmacologic effect. Several lines of evidence converge:

• Subgenual cingulate connectivity — Weigand 2018 demonstrated prospectively that functional connectivity between the individual cortical target (DLPFC) and the subgenual cingulate predicts antidepressant response to rTMS. This finding underpins fMRI-guided targeting approaches and the SAINT protocol.
• Structural change — Furtado 2013 showed increased left amygdala volume in responders and decreased left hippocampus volume in non-responders on neuroimaging, suggesting rTMS “may promote neurogenesis or other effects favoring neuronal plasticity.”
• Cortico-striatal-thalamic-cortical loop — Peters 2016 describes the CSTC loop as a central pathway implicated in psychiatric disease and its response to neuromodulation.
• Salience network disruption across diagnoses — McTeague 2017 analyzed 5,493 patients across MDD, bipolar, schizophrenia, anxiety, and SUDs vs. 5,728 controls and found shared abnormal activation in the anterior cingulo-insular or “salience network.” The authors describe this as a transdiagnostic vulnerability — “networks intrinsic to adaptive, flexible cognition are vulnerable to broad-spectrum psychopathology.”

Cutting edge

Three trends define where the field is moving: precision targeting (fMRI-guided individualization), accelerated protocols (days, not weeks), and prediction (biomarkers and AI to identify who will respond and personalize stimulation).

fMRI-guided targeting

Preliminary work from the Acacia and Harvard collaborative group (n≈195, preprint) compared standard scalp-based targeting to individualized fMRI-guided targeting using the sgACC-anticorrelation principle. Early numbers suggest response rates may rise substantially with fMRI-guided targeting compared with scalp-based methods, with median targeting error under scalp methods of ~30 mm. If replicated, this would support fMRI-guided targeting as a meaningful advance in precision TMS. Specific percentages circulating in industry communications (e.g., 62% vs. 77.5% response, OR 2.3) should be confirmed against the peer-reviewed publication before being cited clinically.

SAINT / SNT

Stanford Neuromodulation Therapy: 5-day accelerated iTBS with individualized fMRI-based targeting. In the pivotal randomized trial, roughly 78.6% of participants met remission criteria after the active arm (Cole 2022). FDA-cleared under K213481. Real-world replication is ongoing; outcomes in community settings remain an active question.

ONE-D

Shorter-course accelerated protocol under active development and study. Preliminary reports (Vaughn 2025) describe encouraging response rates on HDRS and BDI measures in early cohorts, but peer-reviewed publication is pending.

SWIFT

BrainsWay accelerated deep TMS protocol. Industry registration data describe strong response and remission outcomes; FDA clearance has been reported. The specific percentages circulating in manufacturer communications should be confirmed against the peer-reviewed publication and the FDA 510(k) summary before being used in clinical documentation or patient counseling.

Biomarker-guided prediction

A parallel effort aims to predict response before starting a course, and in some cases to stratify patients to the protocol most likely to help them. Several research programs — including work at MUSC, one of the original homes of clinical TMS research — are converging on this goal.

• fMRI-based network signatures — sgACC connectivity patterns and broader DMN/CEN dynamics. Cash 2021 showed that baseline functional connectivity predicts response to standard rTMS. Multi-site replication is ongoing.
• EEG biomarkers — Brainmarker-I (Voetterl 2023, Nature Mental Health), a resting-state EEG-derived measure of individual alpha peak frequency (iAPF) that appears to predict differential response: patients with iAPF near 10 Hz respond better to 10 Hz left DLPFC rTMS, lower iAPF favors sertraline, and higher iAPF favors 1 Hz right DLPFC rTMS.
• EEG-synchronized (closed-loop) TMS — The MUSC Brain Stimulation Lab (Mark George and colleagues) ran a first-in-human randomized trial of prefrontal rTMS synchronized to each patient's individual alpha phase, determined via a pre-treatment combined fMRI-EEG-TMS (fET) scan. Patients whose TMS pulses were time-locked to their personalized “preferred phase” showed entrainment-dependent clinical response (George 2023, Brain Stimulation). A proof-of-concept for individualized closed-loop stimulation.
• Ongoing MUSC work (NCT06043401) — A prospective neuroimaging study at the MUSC Brain Stimulation Service is tracking dynamic brain states across a standard TMS course, asking whether baseline imaging measures can prospectively predict who will respond. Similar Veterans Affairs work (NCT04663481) is evaluating DLPFC-anchored cognitive control circuit connectivity as a predictive biomarker.
• Multimodal ML — combining clinical, imaging, and EEG features. Initial models achieve AUCs around 0.69–0.75 for response and remission (published UCSD work), suggesting modest but real discriminative power. Not yet clinically actionable, but moving in the right direction.

Biomarker-guided prediction is the current research frontier most likely to change day-to-day practice in the next 5–10 years. Done well, it would move TMS from “try it and see” to “this patient's circuit profile suggests high probability of response with protocol X.” Done poorly, it becomes another layer of cost and complexity without commensurate clinical benefit. Worth watching carefully.

Where AI moves TMS forward

Near-term, practical applications:

• Maintenance scheduling based on individual response trajectories rather than fixed calendars.
• Smart maintenance protocols that adapt to relapse signals.
• Registry-scale outcome tracking to move beyond single-center data.
• AI-assisted coil positioning and real-time targeting verification.

Contraindications

The most common reason a referral is declined or delayed. Worth screening for before sending the patient.

Absolute contraindications

• Ferromagnetic metal in or near the head — aneurysm clips, cochlear implants, intracranial stents or coils, deep brain stimulators, shrapnel, or other non-removable ferromagnetic hardware within roughly 30 cm of the coil.
• Active implanted devices in the stimulation field — cochlear implants, vagus nerve stimulators (VNS), and intracranial electrodes.
• Cardiac pacemakers or ICDs where the device or leads are within the magnetic field.
• Medication infusion pumps (e.g., intrathecal pumps) that could be disrupted by the field.

Relative contraindications / caution

• History of seizure or lowered seizure threshold — personal seizure history, recent CNS lesions, recent significant head trauma, withdrawal states, or concurrent proconvulsant medication. TMS lowers the seizure threshold; overall risk is low but not zero.
• Active mania or rapid cycling — risk of treatment-emergent mood elevation, particularly in bipolar-spectrum patients.
• Active substance use — complicates risk assessment, adherence, and interpretation of response.
• Pregnancy — limited data; not an absolute contraindication but warrants case-by-case review with OB and psychiatry.
• Significant hearing loss or inadequate ear protection — coil clicks can reach intensities requiring protection; pre-existing hearing concerns need documentation and appropriate ear protection.
• Unstable medical or psychiatric comorbidity — acute suicidality, unstable cardiac disease, or uncontrolled medical illness may warrant stabilization before starting a course.

Common side effects (not contraindications)

Headache, scalp irritation or discomfort at the stimulation site, transient lightheadedness, and fatigue after sessions. These are usually self-limited and improve over the first week of treatment.

Referral tools

Practical guidance for referring clinicians.

What to include in the referral note

The Prisma Health Neuromodulation Program handles benefits verification and prior-authorization on behalf of each referral. The items below are what we’ll need in the referral note to process authorization efficiently — and, independent of insurance, they are the clinical documentation that supports a good TMS evaluation.

• Current PHQ-9or equivalent severity score.
• Antidepressant trials in the current episodefor each, include class, dose, duration, and reason for stopping or insufficient response. Payers typically require two or more adequate trials from different classes.
• Psychotherapy trialCBT or equivalent, with duration and outcome.
• ECT statusconsidered, offered, or reason not appropriate.
• Contraindication screendocumented, including implants and seizure risk.
• Diagnosis and severitydocumented in the current note, not just the problem list.

When to refer

What we can say honestly

Six statements that hold up across the current evidence base. Useful when talking to patients, families, and skeptical colleagues.

References

Full reference list for material cited above, in AMA format with DOIs and PMIDs where available. Citations marked (verify) are newer or preprint-stage and should be independently confirmed before being cited in clinical documentation.

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2. Schutter DJ. Quantitative review of the efficacy of slow-frequency magnetic brain stimulation in major depressive disorder. Psychol Med. 2010;40(11):1789-95. doi:10.1017/S003329171000005X. PMID: 20102670.
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34. BrainsWay. SWIFT protocol FDA clearance data. 2026. (verify)
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Citations 1–30 and 35–46 have been verified in PubMed/published form. Citations 31–34 are drawn from recent conference proceedings, preprints, or preliminary industry communications and should be independently confirmed before use in patient-facing documentation or consult notes.

Last updated: April 2026 · This page is educational and does not constitute individual clinical advice.