Accelerated TMS: Protocols, Evidence and FDA Status

Accelerated TMS means giving more than one TMS session a day so that a course that would normally take about six weeks is compressed into days or a couple of weeks. The CANMAT 2023 guideline notes that accelerated protocols can shorten a course to "as short as 5 days". Most use intermittent theta burst (iTBS), because each session takes only minutes.

Three accelerated protocols are now FDA-cleared for adult major depression: SAINT (2022), BrainsWay's accelerated deep TMS (2025) and MagVenture's accelerated TMS system (2026). Single-day protocols that combine TMS with medications are not FDA-cleared, and their evidence is limited to small case series. The evidence for accelerated TMS overall is promising but younger and thinner than for standard daily TMS, and the major commercial insurer policies reviewed for this guide still classify it as experimental or unproven.

What makes a protocol "accelerated"

Standard TMS gives one session a day, five days a week. Accelerated schedules change one or more of three things:

• Sessions per day: anywhere from 2 to 10.
• Spacing between sessions: intervals in published studies have ranged from 10 to 480 minutes. A 2026 meta-analysis of 59 studies found the median interval was 50 minutes, and that spacing of roughly 30 to 75 minutes did better than shorter or longer gaps.
• Total dose: accelerated courses often deliver far more pulses than a standard course. In the same meta-analysis, totals ranged from 10,800 to 120,000 pulses.

The rationale comes from plasticity research: repeated stimulation spaced within a day may build on the changes induced by the previous session. That idea is plausible but not proven, and a separate 2026 meta-analysis of sham-controlled trials found "no significant linear dose-response relationships" across frequency, intensity, total pulses or session number. The mechanism is explained in how TMS works.

The main varieties

Two corrections to common claims. BrainsWay's cleared accelerated protocol is not a 5-day course; it spans 6 weeks including the maintenance sessions. And SAINT is no longer the only cleared accelerated option. The SAINT guide and the review of one-day accelerated TMS go into each in depth.

Cleared device vs cleared protocol

An FDA clearance covers a specific device with a specific indication and, for TMS, the treatment parameters described in its submission. That distinction matters more for accelerated TMS than for any other form of the treatment, because almost any modern TMS machine can physically deliver several sessions a day.

The ONE-D single-day protocol is the clearest example. The Clinical TMS Society noted that the device used is FDA-cleared for standard treatment, but the single-day protocol itself "was not FDA cleared". Running an uncleared schedule on a cleared device is off-label use. It is legal in medical practice, but patients should be told, and insurers generally will not pay for it. Medicare's New York policy, for example, expects treatment to "generally follow the protocol and parameters specified in the manufacturer's user manual".

The 2026 MagVenture clearance widened what counts as on-label, covering schedules from 2 to 10 sessions a day, with or without MRI-guided targeting. MagVenture's announcement gave no study sample sizes, so the clinical evidence behind each schedule within that range is best judged from the published trials described below. The clearances held by each manufacturer are listed in TMS devices compared.

What a course looks like in practice

Accelerated treatment days are long. In the SAINT protocol, each of the 10 daily sessions takes about 10 minutes and sessions are separated by 50-minute intervals, so a treatment day runs roughly nine hours from first to last session. Before treatment starts, SAINT requires structural and functional MRI scans to compute the individual target, and the motor threshold is measured by watching for finger movement with EMG, then adjusted for the depth of the frontal target.

BrainsWay's protocol spreads the load differently: five 10-minute sessions on each of six treatment days within two weeks, then two sessions on one day a week for four more weeks, for 38 sessions in all. Research schedules such as 3 sessions a day over three weeks sit between these and a standard course. Whatever the schedule, plan for transport, meals and rest on treatment days, and for someone to check in afterward, because fatigue is common.

How strong is the evidence?

Individual trials

• SAINT: an open-label study of 22 patients reported remission in 19 of 21 who finished, and the follow-up double-blind trial, stopped early for superiority, found remission in 11 of 14 with active treatment vs 2 of 15 with sham. FDA noted uncertainty about the adequacy of blinding.
• Accelerated deep TMS: a BrainsWay-sponsored trial of 104 adults found accelerated H1-coil iTBS non-inferior to standard 18 Hz deep TMS at week 6, with remission reached sooner, 21 vs 28 days. Remission at week 6 was numerically lower with the accelerated protocol, 78.0% vs 87.5%.
• Accelerated iTBS without neuronavigation: a 2025 triple-blind trial of 100 patients reported response of 52% vs 22% and remission of 34% vs 16% with sham. It was a single-center trial, and it suggests an accelerated protocol can separate from sham without MRI-guided targeting.

Pooled evidence and guidelines

A 2026 meta-analysis of 15 sham-controlled trials of accelerated iTBS (704 patients; 11 trials in unipolar and 4 in bipolar depression) found response roughly doubled vs sham, with a number needed to treat of 5 for response and 10 for remission, and similar dropout rates. Only 46% of the trials were at low risk of bias. An earlier 2017 network meta-analysis found accelerated protocols no better than sham, but it drew on a small evidence base searched in 2016.

Guidelines reflect this middle position. CANMAT 2023 rates accelerated iTBS to the left DLPFC second-line, with Level 3 evidence, compared with first-line Level 1 for standard iTBS and 10 Hz rTMS. The 2025 consensus endorsed by the Clinical TMS Society and others says newer forms of TMS "are faster and potentially more effective" and encourages further study of accelerated protocols.

What is not yet known

• Durability. FDA's SAINT summary says effectiveness "has not been established beyond the timepoints evaluated", which was four weeks after treatment. The 2025 consensus also calls for more data on long-term durability.
• Generalizability. All 70 patients in SAINT's FDA submission came from a single site.
• The best dose and spacing, given the conflicting meta-analyses above.
• How results compare with a full standard course in routine practice. For durability of standard TMS, see how long TMS results last.

Risks and tolerability

Accelerated TMS uses the same technology, so the types of side effects are similar: scalp discomfort, headache and fatigue. Packing many sessions into a day can make them more noticeable:

• In the SAINT sham-controlled trial, fatigue was reported by 57% and back or neck pain by 50% of the active group.
• In the accelerated deep TMS trial, adverse events were more common with the accelerated protocol, and two participants stopped because of anxiety and hypomania.
• In the ONE-D case series, seven patients could not tolerate the target intensity.

Seizure risk with TMS is very low overall, but in survey data seizures were "most likely to occur within the first few exposures". Accelerated schedules deliver many first exposures in a single day, so screening for risk factors such as sleep deprivation and alcohol use matters at least as much as with standard TMS. See TMS safety and seizure risk.

Single-day protocols add a separate layer of risk: they pair TMS with off-label medications given to enhance plasticity. The Clinical TMS Society said in 2025 that the evidence did "not meet the threshold to recommend" ONE-D over more established approaches, and that clinics must make the off-label status clear.

Insurance and cost

Coverage is the biggest practical obstacle. Major commercial policies reviewed for this guide treat accelerated TMS as experimental or unproven:

• Aetna lists accelerated TMS and MRI-guided TMS, including SAINT, as experimental and investigational.
• Cigna considers accelerated protocols, including theta burst and SAINT, experimental.
• UnitedHealthcare and Optum list accelerated protocols as unproven.
• MetroPlusHealth, a New York Medicaid plan, cites insufficient evidence for accelerated or theta burst TMS.
• New York's Medicare policy does not mention accelerated TMS by name.

SAINT-type treatment has its own billing codes (0889T to 0892T). Medicare's 2026 hospital outpatient rate for a SAINT treatment day is $3,750.50, compared with $220.60 for a standard TMS session code; these are hospital rates, not office rates. The patient guides on whether accelerated TMS is covered and TMS costs without insurance cover the practical side.

Who accelerated TMS may suit

Accelerated TMS may be worth discussing when:

• Six weeks of daily visits is not feasible because of work, caregiving or travel.
• Faster improvement matters, for example when depression is seriously disrupting work or study, and the person is medically stable.
• The person can afford it or has coverage confirmed in writing.
• The person is comfortable with a treatment whose long-term durability is less well documented.

It is not the right first step for everyone. Consensus guidance says people with psychotic symptoms or acute suicidal ideation "should be considered for other antidepressant treatments with established efficacy", such as ECT. Accelerated TMS is not an emergency treatment, even though its speed is sometimes marketed that way. The research on suicidal thoughts is reviewed in TMS and suicidal thoughts, and other options are compared in TMS vs ECT and TMS vs Spravato. 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.

Questions to ask a clinic

1. Which protocol is this, and is that exact schedule FDA-cleared on the device you use?
2. How is the target chosen: scalp measurement, MRI navigation or functional connectivity?
3. Are any medications given to enhance the effect, and are they being used off-label?
4. What does the published evidence for this specific protocol show, and from how many patients?
5. What follow-up is planned after the treatment days, and what happens if symptoms return?
6. Has my insurer approved this protocol in writing, and what will I owe if it does not pay?

All articles in this series are collected in the TMS guide, and the TMS therapy page describes TMS within psychiatric care.

Frequently asked questions

Is accelerated TMS FDA-cleared?

Some accelerated protocols are: SAINT (2022), BrainsWay's accelerated deep TMS (2025) and MagVenture's accelerated TMS system (2026), all for adult major depression. Single-day protocols combined with medications are not cleared.

Does accelerated TMS work better than standard TMS?

That has not been shown. The best head-to-head trial found accelerated deep TMS non-inferior to the standard deep TMS course, with faster remission but a numerically lower remission rate at week 6. Its main advantage is speed, not a proven higher success rate.

How long do the results of accelerated TMS last?

This is one of the biggest unknowns. FDA's SAINT summary says effectiveness was evaluated only to four weeks after treatment, and expert consensus calls for more durability data.

Will my insurance cover accelerated TMS?

Usually not today. Aetna, Cigna, UnitedHealthcare and Optum policies reviewed in 2026 classify accelerated TMS as experimental or unproven. Get written confirmation before starting.

Is one-day TMS the same as accelerated TMS?

It is the most extreme version. The best-known single-day protocol, ONE-D, combines 20 iTBS sessions with off-label medications and has been studied only in small, unblinded case series. It is not FDA-cleared.

Can accelerated TMS help in a crisis?

No TMS protocol is a crisis treatment. If you are in danger, call or text 988 or go to the nearest emergency room.

Sources

1. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 Update on Clinical Guidelines for Management of Major Depressive Disorder in Adults. Canadian Journal of Psychiatry, 2024. pmc.ncbi.nlm.nih.gov
2. K220177 510(k) Summary: Magnus Neuromodulation System with SAINT Technology. U.S. FDA, 2022. accessdata.fda.gov
3. K251449 510(k) Summary: BrainsWay accelerated Deep TMS. U.S. FDA, 2025. accessdata.fda.gov
4. K260189 510(k) Summary: MagVenture Accelerated TMS (aTMS) Therapy System. U.S. FDA, 2026. accessdata.fda.gov
5. MagVenture Receives FDA Clearance for Accelerated TMS Protocols, Expanding Flexibility for Clinics and Patients. MagVenture (press release), 2026. magventure.com
6. Clinical TMS Society's Statement on Level of Evidence for Single-Day TMS combined with Medications. Clinical TMS Society, 2025. clinicaltmssociety.org
7. Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplastogen-Enhanced techniques in Depression (ONE-D). Research Square (preprint), 2024. doi.org
8. Dose-response associations of total pulse dose and intersession interval with clinical outcomes in accelerated rTMS for major depressive episodes: A systematic review and meta-analysis. Brain Stimulation, 2026. pubmed.ncbi.nlm.nih.gov
9. Protocol-level moderators of antidepressant efficacy in prefrontal rTMS: A sham-controlled meta-analysis of randomized trials. Journal of Affective Disorders, 2026. pubmed.ncbi.nlm.nih.gov
10. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. American Journal of Psychiatry, 2020. pubmed.ncbi.nlm.nih.gov
11. Accelerated TMS with the H1-coil for depression: A multisite, randomized non-inferiority trial. Brain Stimulation, 2026. pubmed.ncbi.nlm.nih.gov
12. Accelerated Theta-Burst Stimulation for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry, 2025. pmc.ncbi.nlm.nih.gov
13. Accelerated intermittent theta-burst stimulation for major depressive episodes: systematic review and dose-response meta-analysis. Brain Stimulation, 2026. pubmed.ncbi.nlm.nih.gov
14. Repetitive Transcranial Magnetic Stimulation for the Acute Treatment of Major Depressive Episodes: A Systematic Review With Network Meta-analysis. JAMA Psychiatry, 2017. pubmed.ncbi.nlm.nih.gov
15. Consensus review and considerations on TMS to treat depression: A comprehensive update endorsed by the National Network of Depression Centers, the Clinical TMS Society, and the International Federation of Clinical Neurophysiology. Clinical Neurophysiology, 2025. doi.org
16. Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Clinical Neurophysiology, 2019. europepmc.org
17. Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. Journal of Clinical Psychiatry, 2018. pmc.ncbi.nlm.nih.gov
18. Addendum B: OPPS Payment by HCPCS Code for CY 2026 (October 2026). Centers for Medicare & Medicaid Services, 2026. cms.gov
19. Transcranial Magnetic Stimulation and Cranial Electrical Stimulation (Clinical Policy Bulletin 0469). Aetna, 2026. aetna.com
20. Transcranial Magnetic Stimulation (Coverage Policy EN0383). Evernorth Health Services (Cigna), 2026. a.static.cigna.com
21. Transcranial Magnetic Stimulation for Treating Physical Health Conditions (2026T0536W). UnitedHealthcare, 2026. uhcprovider.com
22. Behavioral Clinical Policy: Transcranial Magnetic Stimulation (BH803TMS112025). Optum Behavioral Health Solutions, 2026. providerexpress.com
23. Repetitive Transcranial Magnetic Stimulation (TMS) - Policy and Procedure (BMD-110). MetroPlusHealth, 2025. metroplus.org
24. LCD L33398 Transcranial Magnetic Stimulation (version 40). CMS Medicare Coverage Database (Wellpoint Federal), 2026. cms.gov

Educational information, not medical advice. Whether TMS or any treatment fits you is a decision to make with a psychiatrist who knows your history.