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

Sponsor
Brigham and Women's Hospital
Study ID
NCT07043738
Status
Not Yet Recruiting

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Conditions

  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
22 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation — PROCEDURE
    Transcranial magnetic stimulation (TMS) is a focal, non-invasive form of brain stimulation that has FDA clearance for depression. In this study, a form of TMS called accelerated intermittent theta burst stimulation (aiTBS) will be administered under the supervision of a physician with TMS expertise.

Study Details

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.

Key Dates

First listed
Jun 29, 2025
Start date
Aug 3, 2026
Status verified
Jul 2025
Primary completion
Aug 2, 2031
Completion
Aug 31, 2032

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Connectivity-based targeting
    Participants in this group will receive aiTBS with neuronavigation to a treatment target identified with individualized resting state functional connectivity. Participants who receive connectivity-based targeting and who do not meet response criteria (\<50% MADRS improvement) at the post-treatment month 1 visit will be offered the opportunity to opt in and receive another course of aTMS at their scalp-based target.
  • Other: Scalp-based targeting
    Participants in this group will receive aiTBS with neuronavigation to a treatment target identified with scalp based measurements (i.e., Beam F3). Participants who receive scalp-based targeting and who do not meet response criteria (\<50% MADRS improvement) at the post-treatment month 1 visit will be offered the opportunity to opt in and receive another course of aTMS at their connectivity-based target.

Primary Outcome Measure

Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline to one month post treatment ]

Central Contacts

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