Accelerated TMS for Postpartum Depression

(PAiNT Trial)

Overseen By Interventional Psychiatry Research Group

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Ketamine, Esketamine, ECT

Disqualifiers: Preeclampsia, Neurosurgical intervention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 week

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for pregnant or postpartum individuals experiencing major depression. Participants should be interested in a non-invasive brain stimulation treatment called accelerated Transcranial Magnetic Stimulation (TMS).

Inclusion Criteria

Patients will not be scanned after 32 weeks gestational age

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

I am currently pregnant between 14-34 weeks or within a year postpartum.

Exclusion Criteria

≥ 30% change in MADRS score between screening and baseline

I am currently taking a fast-acting antidepressant.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated iTBS treatment with 10 sessions per day for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated TMS

Trial Overview The study tests an accelerated form of TMS, which involves multiple daily treatments over the course of 5 days, as opposed to traditional TMS that extends over 6-8 weeks.

How Is the Trial Designed?

Group I: Open-label aiTBS for pregnant/postpartum individuals Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+