Actively Recruiting
Perinatal Accelerated iTBS Neuromodulation Therapy for Depression in Pregnant and Postpartum Individuals
Led by Brigham and Women's Hospital · Updated on 2025-09-09
24
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an accelerated form of Transcranial Magnetic Stimulation (TMS) to treat depression in pregnant and postpartum individuals. Perinatal depression affects about one in five people during pregnancy and up to one year after birth and is often underdiagnosed and undertreated. This study focuses on a rapid treatment called Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), which delivers multiple daily TMS sessions over five days, aiming to improve depressive symptoms faster than traditional methods. Participants will receive 10 intermittent theta burst stimulation (iTBS) sessions per day, each targeting the dorsolateral prefrontal cortex, for five consecutive days. Each session involves specific brain stimulation pulses delivered at a set intensity. Treatment targets will be personalized using MRI guidance when possible or scalp-based measurements if MRI is not suitable. The total treatment includes 90,000 pulses over the five-day period. During the study, participants will be closely monitored for tolerability, safety, feasibility, and acceptability of the accelerated TMS treatment. Researchers will assess depression severity and effects on birth outcomes and breastfeeding from before treatment through one month after completion. Participants will complete questionnaires and clinical evaluations, and adverse events will be recorded. The study will provide important information on this novel treatment's potential for perinatal depression, with a follow-up period of one month after the treatment ends.
CONDITIONS
Brief Title
Accelerated TMS for Perinatal Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years
- Pregnant individuals between 14 and 34 weeks gestation or within one year after delivery at time of treatment
- No MRI scanning after 32 weeks gestation; scalp-based treatment offered instead
- English proficiency sufficient for informed consent, questionnaires, and treatment
- Primary diagnosis of major depressive disorder per DSM-V with MADRS score greater than 20 and moderate to severe treatment resistance
- Stable antidepressant medication regimen or medication free for at least 4 weeks before treatment and throughout treatment
- Have a primary clinician for psychiatric care and an obstetric provider
- Agree to maintain usual caffeine intake during treatment
You will not qualify if you...
- Current use of rapid acting antidepressants (ketamine, esketamine) or electroconvulsive therapy (ECT)
- Receiving or planning other TMS treatments during the study
- Obstetric concerns such as preeclampsia or frequent painful contractions
- History of neurosurgical intervention for depression, autism spectrum disorder, intellectual disability, severe cognitive impairment, significant neurological illness, untreated endocrine disorder, or investigational drug use during study
- Change of 30% or more in MADRS score between screening and baseline
- Mania, hypomania, psychosis, or active suicidal ideation with plan or recent suicide attempt
- Neurological lesions or contraindications to TMS or MRI
- Moderate or severe substance use disorder or acute withdrawal signs
- Functional impairment from tinnitus
- History of retinal detachment or retinal pathology
- Severe borderline personality disorder
- Any condition deemed by the principal investigator to interfere with the study or increase risk to participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 consecutive days
Participants receive 10 intermittent theta burst stimulation (iTBS) treatment sessions per day for 5 consecutive days targeting the dorsolateral prefrontal cortex to treat perinatal depression.
Daily visits for 5 days
Duration - 1 month
Participants are monitored for safety, tolerability, and treatment effects including depression symptoms and birth outcomes for up to 1 month after treatment.
1 visit approximately 1 month after treatment
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
I
Interventional Psychiatry Research Group
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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