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Accelerated TMS for Perinatal Depression

Perinatal Accelerated iTBS Neuromodulation Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In this study, we will offer an accelerated form of TMS that involves multiple daily treatments for 5 days."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a faster schedule of TMS for depression in people who are pregnant or gave birth within the past year. TMS stimulates the brain without surgery. The study gives several treatments each day for 5 days, instead of daily treatments for 6–8 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–55 years old.
  • Be 14–34 weeks pregnant or within one year after giving birth when treatment starts.
  • Brain scans are not done after 32 weeks of pregnancy. After that, the team uses points on the scalp to choose where to treat.
  • Know enough English to understand and agree to the study, answer questions, and take part in treatment.
  • Have major depression as your main diagnosis, a depression score above 20 on the MADRS rating scale, and depression that has been moderately to very hard to treat.
  • Keep antidepressant medicines unchanged, or stay off them, for 4 weeks before treatment and during treatment. If medically appropriate, keep this the same until one month after treatment.
  • Have a mental health clinician responsible for your care before, during, and after the study, plus a pregnancy care provider.
  • Keep your usual intake of coffee, tea, soft drinks, chocolate, and similar products during treatment.

Who can't join

  • Use ketamine, esketamine, or ECT for depression at the same time; receive or plan other TMS during the study; or receive an experimental drug or treatment during the study.
  • Have preeclampsia, a serious pregnancy problem involving high blood pressure, or painful contractions more often than once every 10 minutes.
  • Have a history of brain surgery for depression, autism, intellectual disability, severe thinking problems, a major brain or nerve illness, or a hormone disorder that is not treated well enough.
  • Have a depression rating score that changes by 30% or more between screening and the visit before treatment.
  • Have mania or hypomania (unusually high energy or mood), psychosis (trouble knowing what is real), current suicidal thoughts with a plan and some intent to act, or a suicide attempt in the past 3 months.
  • Have brain damage, a condition that makes TMS or MRI unsafe, a current moderate or severe substance use disorder, or signs of substance withdrawal.
  • Have ringing in the ears that limits daily activities, a history of a detached retina or another problem with the light-sensing layer at the back of the eye, or severe borderline personality disorder.
  • Have any other condition that the lead researcher thinks could disrupt the study or make participation more risky.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MA