Not Yet RecruitingNot Applicable

Imaging- vs. Scalp-Targeted Accelerated TMS for Depression: The Number Needed to Scan Trial

160 participantsStarted 2026-08-03

Plain-language summary

Transcranial magnetic stimulation(TMS) is a non-invasive form of brain stimulation that is cleared by the United States Food and Drug Administration (FDA) for depression. Conventional TMS involves daily weekday treatments for 6-8 weeks. These treatments are targeted using each person's scalp measurements. With conventional TMS, approximately 50-55% of people show a 50% or more improvement in depressive symptoms (in other words, they "respond" to treatment). Studies are trying to make TMS work better and faster. A new form of TMS called accelerated TMS (aTMS) involves mutliple treatments a day. One specific aTMS protocol involves 10 treatments per day for 5 days. These treatments are targeted using each person's brain scan (magentic resonance imaging, MRI). With this specific aTMS protocol, approximately 70-90% of people show a 50% or more imporvement in depressive symptoms. While these results are exciting, scientists are not sure why this specific aTMS protocol works better than conventional TMS. It could be the dose and schedule of treatment, or it could be the MRI-based targeting. Answering this question is important because MRI-based targeting is expensive and difficult to do in many settings. This study aims to determine if MRI-based targeting is better than scalp-based targeting for aTMS for depression. In this study, everyone who enrolls and meets criteria will be randomly assigned to MRI- versus scalp-based aTMS targeting.

Who can participate

Age range

22 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 22-80 * English proficiency sufficient for informed consent, questionnaires/tasks, and treatment * Primary diagnosis of major depressive disorder per DSM-V criteria (Quick Structured Clinical Interview for DSM-5) * \>20 on Beck Depression Inventory (BDI) * \>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) * Moderate to severe level of treatment resistance (Maudsley Staging Method) * Stable antidepressant medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the 1-month post-treatment visit. * Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial * Agreement to lifestyle considerations * Abstain from becoming pregnant from screening to one-month after treatment (the MRI visit) * Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment * Abstain from alcohol, tobacco, and recreational drugs for at least 24 hours before the start of each MRI and TMS session

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compares two ways of targeting TMS — one guided by brain imaging and one using standard scalp measurements — so could you explain whether having a brain scan done beforehand might make a meaningful difference in how well TMS works for my depression?
2Since this trial isn't recruiting yet, is it worth waiting for it to open, or would starting a standard TMS treatment now be a better option for my situation?
3The trial is measuring depression severity using something called the MADRS scale — can you help me understand what kind of improvement on that scale would actually feel meaningful in my day-to-day life?
4Because this trial doesn't have a traditional phase number, what does that tell us about how much is already known about the safety and effectiveness of the two TMS targeting approaches being compared?
5If I were eventually eligible for this trial, what would participation actually involve in terms of appointments, brain scans, or TMS sessions, and how might that fit with my work or caregiving responsibilities?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Montgomery-Åsberg Depression Rating Scale (MADRS)

Timeframe: Baseline to one month post treatment

Trial details

NCT IDNCT07043738

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-08-02

Contact for this trial

Interventional Psychiatry Research Group

6175253536 bwhtmstrials@bwh.harvard.edu

View on ClinicalTrials.gov More Major Depressive Disorder (MDD) trials