Recruiting

TMS

Sponsor:

Brigham and Women's Hospital

Code:

NCT06968390

Conditions

Perinatal Depression

Post Partum Depression

Major Depressive Disorder

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

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

Study ID

NCT06968390

Start date

Aug 5, 2025

Status verified date

May, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Open-label aiTBS for pregnant/postpartum individuals

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.

Interventions

Transcranial Magnetic Stimulation

Non-invasive form of brain stimulation.

Primary outcome measure

  • Tolerability as measured by ratings of the Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 1 month after treatment ]
  • Acceptability as measured by percentage of individuals who complete an entire treatment course [ Time Frame: 1 month after treatment ]
  • Safety as measured by reports of adverse events [ Time Frame: 1 month after treatment ]
  • Feasibility as measured by the number of individuals treated throughout the study [ Time Frame: From the beginning to the end of the study ]

Central Contacts and Locations

Central contacts

Interventional Psychiatry Research Group

617 525 3536mgbpaint@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Interventional Psychiatry Research Group

617 525 3536mgbpaint@mgb.org

Principal Investigator:

Joseph J Taylor, MD, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 9, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-09-09.