Accelerated TMS for Perinatal Depression

This study is looking at an accelerated form of Transcranial Magnetic Stimulation (TMS) for depression during pregnancy and after childbirth. TMS is a non-invasive (doesn't involve surgery or breaking the skin) way to stimulate the brain, already approved by the FDA for depression. Typically, TMS involves daily treatments for 6-8 weeks, but this study will use an accelerated version with multiple treatments over 5 days. We want to see how well people tolerate this treatment, if they complete the full course, and if there are any side effects. You can join if you are a woman between 18 and 55 years old, and are 14-34 weeks pregnant or within one year of giving birth. This study plans to enroll 24 participants, but its current recruitment status is unclear.

Study design: This is an interventional study with a planned enrollment of 24 participants. The phase of the study is not specified.
What's involved: Participants will receive multiple daily treatments of accelerated Transcranial Magnetic Stimulation (TMS) over 5 days.
Compensation: Not stated in the trial record.
Follow-up: Your tolerability, acceptability, and safety will be measured at 1 month after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Accelerated TMS for Perinatal Depression

Recruiting

NAAges 18–55Interventional

Brigham and Women's Hospital

~24 participants

Updated 2025-09-09 on ClinicalTrials.gov

What's tested:Transcranial Magnetic Stimulation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Tolerability as measured by ratings of the Client Satisfaction Questionnaire (CSQ-8)

Measured over 1 month after treatment

+3 more outcomes measured

Conditions

Perinatal Depression

Post Partum Depression

Major Depressive Disorder

Where it's being run

1 sites across 1 states

Massachusetts1

Who to contact

Interventional Psychiatry Research Group

[email protected]

617 525 3536

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-55

All individuals must be 14-34 weeks gestational age or within one year of delivery at the time of treatment. The odds of delivery nears 10% after 36 weeks, which would limit participants from being able to complete the study and interfere with the primary study aim to understand safety and tolerability. Additionally, after 36 weeks, the standard of care is weekly obstetric check-in visits, which would be challenging for patients to complete given the time demands of the study protocol.

Patients will not be scanned after 32 weeks gestational age due to the time needed to construct the individualized treatment target. Individuals seeking treatment beyond 32 weeks will be offered scalp-based target localization so as not to limit patient access to care.

English proficiency sufficient for informed consent, questionnaires/tasks, and treatment

Primary diagnosis of major depressive disorder per DSM-V criteria (MINI International Neuropsychiatric Interview/ Structured Clinical Interview for DSM-5): \>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and 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 treatment course. We request that this regimen remain stable until the 1 month post-treatment if clinically appropriate.

Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial in addition to an obstetric provider responsible for obstetric care.

Agreement to lifestyle considerations: Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment

Exclusion

Concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)

Receiving or planning to receive other TMS treatments during course of participation

Obstetric concerns: Preeclampsia and/or current frequent, painful contractions (more than one every 10 minutes)

History of: Neurosurgical intervention for depression, autism spectrum disorder, intellectual disability, severe cognitive impairment, significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion), untreated or insufficiently treated endocrine disorder, and/or treatment with investigational drug or intervention during the study period

≥ 30% change in MADRS score between screening and baseline

Anyone presenting with: Mania or hypomania, psychosis, active suicidal ideation with plan and some intent to act or a suicide attempt (defined by C-SSRS) within the past 3 months, neurological lesion, contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia \> 4 hours per night with hypnotic, etc.), and/or current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal

Existing tinnitus (ringing in the ears) that causes functional impairment

History of retinal detachment or other retinal pathology

Severe borderline personality disorder

Any other condition deemed by the PI to interfere with the study or increase risk to the participant

What this trial measures

Tolerability as measured by ratings of the Client Satisfaction Questionnaire (CSQ-8)1 month after treatment
The CSQ-8 asks individuals about their overall experience with aTMS.Higher scores indicate a greater level of tolerability. We hypothesize that participants will report high levels of treatment satisfaction (\>24) on the Client Satisfaction Questionnaire (CSQ-8). The primary outcome will be a composite defined as meeting 3 out of 4 metrics listed here.
Acceptability as measured by percentage of individuals who complete an entire treatment course1 month after treatment
Higher percentage of individuals who completed an entire course (i.e., 50 treatments) indicates higher acceptability. We hypothesize that 9/12 participants will complete at least 75% of treatments. The primary outcome will be a composite defined as meeting 3 out of 4 metrics here.
Safety as measured by reports of adverse events1 month after treatment
We will monitor and report the rate of serious adverse events, including maternal seizures in the sample. We hypothesize that there will be no serious adverse events.
Feasibility as measured by the number of individuals treated throughout the studyFrom the beginning to the end of the study
Report of the number of individuals who received treatment throughout the entire study (i.e., approximately 2 years). We hypothesize that we will be able to enroll and treat 12 participants in two years. The primary outcome will be a composite defined as meeting 3 out of 4 metrics here.

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