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?

This trial explores a new treatment for postpartum depression using accelerated Transcranial Magnetic Stimulation (TMS). TMS is a non-invasive treatment that uses magnetic fields to stimulate specific brain areas. This study tests a faster version with multiple sessions over five days to determine its effectiveness and safety for pregnant and postpartum individuals experiencing major depression. Individuals who have not found success with other treatments and are stable on their current medications might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for postpartum depression.

Do I have to stop taking my current medications for the trial?

You need to stay on a stable antidepressant medication regimen, or remain medication-free, for 4 weeks before starting the treatment and continue this regimen throughout the trial. If it's clinically appropriate, you should also keep this regimen stable for one month after the treatment.

What prior data suggests that accelerated TMS is safe for postpartum depression?

Research has shown that accelerated Transcranial Magnetic Stimulation (TMS) is generally safe and well-tolerated. This treatment uses magnetic fields to stimulate the brain and has already received FDA approval for treating depression. Studies have found that the side effects of accelerated TMS resemble those of regular TMS, typically involving mild headaches or scalp discomfort. Serious side effects, such as seizures, are rare. Patients who have tried accelerated TMS have not reported more negative effects than those using standard TMS. This suggests that accelerated TMS is a promising option for individuals exploring new treatments for postpartum depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for postpartum depression, like antidepressants or psychotherapy, Accelerated TMS (Transcranial Magnetic Stimulation) offers a non-invasive approach that targets the brain directly. This treatment is unique because it uses repetitive magnetic pulses focused on the dorsolateral prefrontal cortex, a brain area linked to mood regulation. What really sets this method apart is its speed — it delivers 10 sessions a day over five days, potentially offering quicker relief than traditional therapies, which can take weeks to show results. Researchers are excited because this could provide a faster-acting, drug-free alternative for new mothers struggling with postpartum depression.

What evidence suggests that accelerated TMS is effective for postpartum depression?

Research has shown that Transcranial Magnetic Stimulation (TMS) is a promising and safe treatment for postpartum depression. Traditional TMS typically requires daily sessions over several weeks, but accelerated TMS aims to shorten this period. In this trial, participants will receive accelerated TMS, involving multiple sessions in a short time, to speed up recovery. Early results suggest that repeated TMS sessions can effectively reduce symptoms of postpartum depression. Specifically, a small study found that TMS improved mood in women with this condition. This new approach could potentially offer quicker relief for those experiencing postpartum depression. ^{1 2 6 7 8}

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+

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06968390

NCT06968390 | Accelerated TMS for Perinatal Depression Study Overview. Brief Summary. We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S266691532200049X

Is repetitive transcranial magnetic stimulation (rTMS) an ... RTMS is a new treatment option with promise as an effective and safe treatment for postpartum and peripartum depression.

4. womensmentalhealth.org womensmentalhealth.org/posts/tms-for-ppd/

Is Transcranial Magnetic Stimulation Effective ... A pilot study from Cox and colleagues looks at the efficacy of repetitive TMS or rTMS in a group of women with postpartum depression (PPD), adding to the ...

5. nature.com nature.com/articles/s41386-023-01599-z

Accelerated TMS - moving quickly into the future of ... Accelerated TMS is an emerging application of Transcranial Magnetic Stimulation (TMS) aimed to reduce treatment length and improve response time.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10700378/

Accelerated TMS - moving quickly into the future of depression ... Accelerated TMS is an emerging application of Transcranial Magnetic Stimulation (TMS) aimed to reduce treatment length and improve response time.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022395622003430

A transdiagnostic review of safety, efficacy, and parameter ... Accelerated TMS is safe and well tolerated, with similar rates of seizure and side effects as once daily rTMS. •. In aTMS for depression, the average response ...

8. trialx.com trialx.com/clinical-trials/listings/314491/accelerated-tms-for-perinatal-depression/

Accelerated TMS for Perinatal Depression We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals. TMS is a ...