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New brain zapping method aims to lift depression in just 5 days

NCT ID NCT05819021

Symptom relief Sponsor: Magnus Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called SAINT® that delivers a special type of brain stimulation (accelerated TMS) to treat major depression. It involves 1000 adults who haven't gotten enough relief from standard antidepressants. Participants get 10 treatments each day for 5 days, with the goal of quickly improving their symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAINT® Neuromodulation System (accelerated TMS device)
What this could lead to
If successful, this could offer a faster, more personalized treatment option for people with depression who haven't responded to medication.
What could go wrong
This is an observational study, not a randomized controlled trial, so results may be less conclusive. The treatment is intensive (10 sessions daily for 5 days) and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants who fulfill all the inclusion criteria and none of the exclusion criteria will be enrolled into the study. Each participant will read and sign the IRB approved informed consent form prior to any screening or study procedures being performed. This open-label study involves an evaluation of the safety and effectiveness of an acute course of the SAINT® NMS.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult males or females, 18 and older, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. 2. Confirmed primary clinical diagnosis of major depressive disorder (MDD) without psychotic features consistent with DSM-V criteria. 3. No medical conditions that would preclude the safe use of TMS. 4. Primary psychiatrist has determined TMS to be an appropriate clinical option. 5. Able to provide consent and comply with all study requirements. 6. Negative pregnancy test at the intended time of SAINT™ 5-day acute course treatment and agreement to use effective birth control during SAINT® acute therapy. Exclusion Criteria: 1. Have any contraindication to TMS (section 2 User Manual). 2. Have any contraindication to receiving an MRI 3. Participants with an abnormal brain MRI as determined by PI, study physician or designee. 4. Deemed by the PI, study physician or designee to be a high risk of suicide or has made a suicide attempt within the last 6 months. 5. Treatment dose with cortical depth adjustment is greater than 120% motor threshold and cannot be completed.

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Conditions

The condition(s) this trial relates to.

Depression Depressive Disorder, Treatment-Resistant major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

  • Acacia Research Center

    Sunnyvale, California, 94087, United States

  • Boston Precision Neurotherapeutics

    Natick, Massachusetts, 01760, United States

  • BrainHealth Solutions

    Costa Mesa, California, 92626, United States

  • Fermata

    Brooklyn, New York, 11249, United States

  • Integral TMS

    Sunnyvale, California, 94085, United States

  • LA TMS

    Los Angeles, California, 90025, United States

  • Seattle Neuropsychiatric Treatment Center

    Seattle, Washington, 98104, United States

More trials for these conditions

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