Brain stimulation for depression: TMS, deep brain stimulation and focused ultrasound

How do accelerated TMS, deep brain stimulation and focused ultrasound compare for depression on regulatory status, invasiveness, course length, trial results and size of the evidence base?

The three approaches differ widely in how invasive they are and how much human evidence exists for depression. Of the three, only accelerated TMS has a regulator clearance for depression in the sources read, and its trial figures come from small studies.

Brain stimulation for depression: TMS, deep brain stimulation and focused ultrasound. Each cell shows a value, how well it is evidenced, and its sources.
Option	Regulatory status for depressionNamed regulator and year of clearance or approval for depression, as stated in the decision record.	InvasivenessWhether the treatment needs surgery or an implant. Describes the method only, not its risks.	Length of a treatment courseNumber of sessions and the calendar time for a typical course, in sessions, days or weeks.	Response or remission rate in a named trialPercentage of participants reaching remission or response in a named trial, with the number of participants and the comparison arm. Unit: percent of participants.	Size of the evidence baseNumber and type of human studies found in the sources read, such as randomised trials or case reports.
Accelerated TMS	FDA 510(k) K220177, 1 September 2022: Magnus SAINT system, adults with major depressive disorder not improved by prior antidepressants (US).Demonstrated[7]	No reliable public figure	SAINT: 50 sessions over 5 consecutive days. Standard 10 Hz rTMS: 5 days a week for 4 to 6 weeks.Demonstrated[1][4]	Remission at one month (MADRS 10 or lower): 50.0% active SNT vs 20.8% sham. Single site, 48 randomised (24 per arm), p = 0.035.Demonstrated[3]	14 studies in a 2024 meta-analysis (4 RCTs). Two sham-controlled SNT trials of 29 and 48 people.Demonstrated[5][2][3]
Deep brain stimulation	No reliable public figure	Surgical. Electrodes are implanted in the brain before randomisation.Demonstrated[6]	The 2017 trial had a six-month double-blind phase (active or sham stimulation), followed by six months of open-label stimulation.Demonstrated[6]	Response (40% or more fall in severity), months 4 to 6: 20% active vs 17% sham, not statistically significant. 90 people (60 active, 30 sham).Demonstrated[6]	The sources read include one sham-controlled RCT of 90 people (2017) and no other depression trial.Demonstrated[6]
Focused ultrasound neuromodulation	No reliable public figure	Described as non-invasive. The review says tFUS delivers mechanical acoustic energy that can penetrate deep brain structures.Demonstrated[8]	No reliable public figure	No reliable public figure	The 2025 systematic review of motor and sensory functions included 34 primary studies, none on depression or mood. No tFUS depression study was found in the sources read.Demonstrated[8]

Brain stimulation for depression: TMS, deep brain stimulation and focused ultrasound. Each cell shows a value, how well it is evidenced, and its sources.

Option

Regulatory status for depressionNamed regulator and year of clearance or approval for depression, as stated in the decision record.

InvasivenessWhether the treatment needs surgery or an implant. Describes the method only, not its risks.

Length of a treatment courseNumber of sessions and the calendar time for a typical course, in sessions, days or weeks.

Response or remission rate in a named trialPercentage of participants reaching remission or response in a named trial, with the number of participants and the comparison arm. Unit: percent of participants.

Size of the evidence baseNumber and type of human studies found in the sources read, such as randomised trials or case reports.

Accelerated TMS

FDA 510(k) K220177, 1 September 2022: Magnus SAINT system, adults with major depressive disorder not improved by prior antidepressants (US).Demonstrated[7]

No reliable public figure

SAINT: 50 sessions over 5 consecutive days. Standard 10 Hz rTMS: 5 days a week for 4 to 6 weeks.Demonstrated[1][4]

Remission at one month (MADRS 10 or lower): 50.0% active SNT vs 20.8% sham. Single site, 48 randomised (24 per arm), p = 0.035.Demonstrated[3]

14 studies in a 2024 meta-analysis (4 RCTs). Two sham-controlled SNT trials of 29 and 48 people.Demonstrated[5][2][3]

Deep brain stimulation

No reliable public figure

Surgical. Electrodes are implanted in the brain before randomisation.Demonstrated[6]

The 2017 trial had a six-month double-blind phase (active or sham stimulation), followed by six months of open-label stimulation.Demonstrated[6]

Response (40% or more fall in severity), months 4 to 6: 20% active vs 17% sham, not statistically significant. 90 people (60 active, 30 sham).Demonstrated[6]

The sources read include one sham-controlled RCT of 90 people (2017) and no other depression trial.Demonstrated[6]

Focused ultrasound neuromodulation

No reliable public figure

Described as non-invasive. The review says tFUS delivers mechanical acoustic energy that can penetrate deep brain structures.Demonstrated[8]

No reliable public figure

The 2025 systematic review of motor and sensory functions included 34 primary studies, none on depression or mood. No tFUS depression study was found in the sources read.Demonstrated[8]

What the table shows

Of the three options, only accelerated TMS has a regulator clearance for depression in the sources read: an FDA 510(k) decision dated 1 September 2022 for the SAINT system.
Deep brain stimulation requires surgery. The sham-controlled trial in the sources read reported 20% response with active stimulation and 17% with sham, which was not statistically significant.
Focused ultrasound is described as non-invasive. The 2025 systematic review of motor and sensory functions found no depression study among its 34 primary studies, so the sources read hold no tFUS depression evidence.
The accelerated TMS evidence in the sources read is a 2024 meta-analysis of 14 studies, including 4 randomised trials, and two sham-controlled SNT trials with 29 and 48 participants.

Read with care

These are research trial figures with selected participants, not routine clinical outcomes, so they are not comparable with each other or with commercial service data.
Outcome measures differ: the SNT trial counts remission as a MADRS score of 10 or lower at one month, while the DBS trial counts response as a 40% fall in severity over months 4 to 6.
Blank cells mean no reliable public figure was found in the sources read. They do not show that no data exists.
The 2017 DBS trial was funded by Abbott (formerly St Jude Medical), a device maker. The accelerated TMS trials are small, and the 2026 SNT trial was single-site.

Sources

peer reviewed paper
Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression
Cole EJ et al.. American Journal of Psychiatry, 7 Apr 2020. Accessed 21 Oct 2026.
peer reviewed paper
Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial
Cole EJ et al.. American Journal of Psychiatry, 29 Oct 2021. Accessed 21 Oct 2026.
peer reviewed paper
Stanford neuromodulation therapy for treatment-resistant depression: a randomized controlled trial confirming efficacy, and an EEG study providing insight into mechanism of action and a potentially predictive biomarker of efficacy
Kratter IH, Austelle CW, Lissemore JI et al.. World Psychiatry, 14 Jan 2026. Accessed 21 Oct 2026.
peer reviewed paper
Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial
Blumberger DM et al.. The Lancet, Apr 2018. Accessed 21 Oct 2026.
review article
Short-term and long-term efficacy of accelerated transcranial magnetic stimulation for depression: a systematic review and meta-analysis
Shi R et al.. BMC Psychiatry, 7 Feb 2024. Accessed 21 Oct 2026.
peer reviewed paper
Subcallosal cingulate deep brain stimulation for treatment-resistant depression: a multisite, randomised, sham-controlled trial
Holtzheimer PE et al.. The Lancet Psychiatry, 4 Oct 2017. Accessed 21 Oct 2026.
other
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K: 510(k) K220177
Innolitics (mirror of the FDA 510(k) database record), 1 Sept 2022. Accessed 21 Oct 2026.
review article
Neuromodulation effects of low-intensity transcranial focused ultrasound in human, a systematic review focusing on motor and sensory functions
Heng-Chen Ho, Wen-Shiang Chen, Ming-Yen Hsiao. Journal of NeuroEngineering and Rehabilitation, 28 Nov 2025. Accessed 21 Oct 2026.