A curated, citation-disciplined library of the studies behind BrainsWay Deep TMS — the pivotal RCTs that drove FDA clearances, the real-world cohorts that exceed them (with the selection caveats we always disclose), the meta-analyses, the safety data, and the negative trials we believe patients should know about.
This page is for patients, families, and referring clinicians who want the underlying data — not marketing claims. Every entry below links to the original peer-reviewed source. We have organized them by category, with the most clinically decisive evidence at the top.
Note on real-world numbers vs. RCT numbers: real-world post-marketing studies (Tendler 2023, Roth 2024, Roth 2025) report substantially higher response and remission rates than the original RCTs. Reasons include selection (only patients who tolerate ≥30 sessions are analyzed), naturalistic placebo response, concurrent treatments, and self-report scales. Patients should be counseled that personal odds are likely closer to the RCT figures.
Sham-controlled randomized trials underlying FDA clearances. The strongest causal evidence we have.
Finding. 4-week effect size on HAM-D 0.76 (p=0.008); response 38% active vs 21% sham; remission 33% vs 15%.
Why it matters. Established the H1 coil for MDD; the basis of the original 2013 FDA clearance.
Read source →Finding. 6-week YBOCS response 38% active vs 11% sham (p=0.003); 1-month sustained response 45% vs 18%.
Why it matters. First TMS device ever cleared by the FDA for OCD; the H7 coil targets a different circuit than H1.
Read source →Finding. 4-week continuous quit rate 28% active vs 12% sham (p=0.005), 18 sessions over 6 weeks.
Why it matters. First brain-stimulation device cleared by the FDA for any addiction.
Read source →Finding. HAM-D17 response: H1 59%, F8 41%, no-stim control 8% (p=0.048 H1 > F8).
Why it matters. The single industry-independent head-to-head trial showing H1 advantage over figure-8.
Read source →Finding. HDRS-21 reduction 19.0 (accelerated, 6 days) vs 19.8 (standard, 6 weeks). Response 88% vs 88%. Remission 78% vs 88%. Non-inferiority met.
Why it matters. Basis of the September 2025 FDA clearance for accelerated Deep TMS — 6-day acute phase with 4-week continuation.
Read source →Finding. MADRS percent reduction at 4 weeks: 52.5% active vs 11.1% sham. Remission 46.2% at 4 weeks (57.1% immediately post-treatment). Cohen's d ~ 2.0.
Why it matters. Established figure-8 accelerated iTBS as a viable option — the basis of the 2022 Magnus Medical SAINT clearance (separate device from BrainsWay).
Read source →Post-marketing data from large community cohorts. Numbers are higher than RCTs; selection effects must be communicated.
Finding. 30 sessions: 82% response, 65% remission. HDRS-specific: 72% response, 72% remission. Sustained at next assessment in 84% of responders.
Why it matters. The largest real-world Deep TMS dataset for MDD. Real-world numbers exceed RCT figures; selection effects (only patients completing 30+ sessions analyzed) should be communicated to patients.
Read source →Finding. 30 sessions: 79% response, 60% remission. No cognitive worsening.
Why it matters. Supported the June 2024 FDA expansion of the H1 indication to ages 22–86. Cognitive safety contrasts with ECT.
Read source →Finding. 36 sessions: PHQ-9 reduction of 12.1 points, 66% response. Discontinuation ~4%. One convulsive syncope (TBI history).
Why it matters. The largest adolescent neuromodulation dataset published. Supported the November 2025 adolescent FDA clearance.
Read source →Finding. 15 sessions: 65% response, 33% remission. Effects independent of age, sex, or concurrent SSRI/SNRI.
Why it matters. Real-world OCD outcomes substantially exceed the original pivotal trial figures.
Read source →Finding. 80% response, 51% remission. 6-month durability: 93% of responders.
Why it matters. Supports use of accelerated H1 protocols in real-world community settings.
Read source →Quantitative pooling of multiple trials — the way the field as a whole reads the literature.
Finding. Hedges' g = −1.32 (depression), g = −1.28 (anxiety); both p < .001.
Why it matters. Pooled evidence base for Deep TMS in TRD; combined dTMS + medications reaches significance for response and remission.
Read source →Finding. Pooled effect on anxiety g = 0.55; H1 superior to figure-8 (p = 0.042). Higher baseline anxiety predicts *greater* H1 response (opposite of meds and F8).
Why it matters. Mechanistic rationale for the 2021 FDA clearance of BrainsWay for anxious depression.
Read source →Finding. Strongest evidence: OCD, substance use, MDD/BD depressive episodes. Weaker for ADHD, PTSD, AD/MCI, schizophrenia.
Why it matters. GRADE-rated low risk of bias overall. Useful for understanding the boundaries of where Deep TMS evidence is strong.
Read source →Aggregate adverse-event data across multiple sham-controlled trials.
Finding. Headache, application-site pain, transient jaw twitching most common. Seizure < 0.1%. No cognitive effects.
Why it matters. The largest aggregate Deep TMS safety dataset published; confirms favorable tolerability profile.
Read source →Imaging and electrophysiology studies — what the brain actually does during and after Deep TMS.
Finding. Stronger baseline DLPFC-sgACC anti-correlation predicts better response. Effective treatment increases anti-correlation post-treatment.
Why it matters. The dominant mechanistic frame for prefrontal TMS. Replicated 50% vs 21% sham remission in 2026 Stanford SNT replication.
Read source →Trials that did not work. The honest version of the literature includes these.
Finding. HAC-coil + brief trauma exposure failed to demonstrate efficacy over sham.
Why it matters. Deep TMS does NOT have FDA clearance for PTSD. This is critical clinical-honesty context — be cautious of any clinic claiming Deep TMS treats PTSD as a primary indication.
Read source →Finding. No significant benefit over sham on CDRS-R.
Why it matters. A negative figure-8 trial. Combined with another negative trial (Zhang 2024), it illustrates why the BrainsWay adolescent clearance rests on real-world evidence rather than a sham-controlled RCT of the H1 coil specifically.
Response typically means a ≥50% reduction in the depression-rating score the trial used (HDRS, MADRS, or PHQ-9). Remission typically means a score below a defined threshold — essentially, “no longer clinically depressed” on that measure. For OCD trials, the analogous scale is YBOCS.
Effect size (Cohen’s d, Hedges’ g) is a way of comparing the size of treatment effects across studies. Roughly: 0.2 = small, 0.5 = medium, 0.8 = large. The Stanford SNT/SAINT trials reported d ≈ 2.0, an unusually large effect for an antidepressant intervention.
NCT numbers (e.g., NCT06357832) are unique trial identifiers at ClinicalTrials.gov; they let you trace exactly which study supported a given clearance.
Email it to us. We update this library when meaningful new evidence is published, and we are happy to talk through how a specific study would or would not change our recommendation in your case.
Related reading. How BrainsWay Deep TMS works · The history of TMS, FDA timeline included · All conditions we treat · Safety page