Accelerated TMS for Perinatal Depression

NCT06968390 | Recruiting FDA Device

• 2 other identifiers: 2025P001058Women's Brain Initiative
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals. TMS is a focal, non-invasive form of brain stimulation that is cleared by the Food and Drug Administration for depression. Typically, traditional TMS involves daily treatments for 6-8 weeks. In this study, we will offer an accelerated form of TMS that involves multiple daily treatments for 5 days.

Conditions

Perinatal Depression; Post Partum Depression; Major Depressive Disorder

Keywords

TMS; Accelerated TMS; Perinatal Depression; Perinatal; Postpartum; Postpartum Depression; Major Depressive Disorder; Pregnant

Outcome Measures

Primary Outcomes (4)

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

  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.

  1 month after treatment

• Acceptability as measured by percentage of individuals who complete an entire treatment course

  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.

  1 month after treatment

• Safety as measured by reports of adverse events

  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.

  1 month after treatment

• Feasibility as measured by the number of individuals treated throughout 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.

  From the beginning to the end of the study

Secondary Outcomes (2)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  From baseline to 1 month post treatment.

• Assess the effects of accelerated TMS on birth outcomes and lactation

  Throughout the 5 days of treatment to 1 month post treatment

Other Outcomes (13)

• Beck Depression Inventory (BDI)

  Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment

• Beck Anxiety Inventory (BAI)

  Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment

• Young Mania Rating Scale (YMRS)

  Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment

Study Arms (1)

Open-label aiTBS for pregnant/postpartum individuals

EXPERIMENTAL

10 iTBS treatment sessions per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total) to the dorsolateral prefrontal cortex (DLPFC). In the unlikely event that a participant is late for an hourly treatment, then the treatment will be delayed accordingly. The minimum gap between treatments will be 25 minutes. Each iTBS treatment will consist of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation will be delivered at 90% resting motor threshold (rMT), adjusted for depth of the identified functional connectivity target or based on traditional scalp measurements.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Non-invasive form of brain stimulation.

Also known as: TMS, Accelerated intermittent theta burst stimulation, aiTBS

Open-label aiTBS for pregnant/postpartum individuals

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Interventional Psychiatry Research Group

CONTACT

617 525 3536; mgbpaint@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director of TMS, Center for Brain Circuit Therapeutics, Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 13, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-05

Locations

US (1)