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Not yet recruitingNCT07571187Project MOMUpdated May 6, 2026

Transcranial Magnetic Stimulation as a Treatment for Postpartum Obsessive Compulsive Disorder

An interventional study of Accelerated Continuous Theta Burst Stimulation (cTBS) in Postpartum Obsessive Compulsive Disorder, sponsored by Butler Hospital. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The goal of this clinical trial is to learn if accelerated transcranial magnetic stimulation (TMS) is a feasible treatment for obsessive compulsive disorder that worsens or starts within 12 months of childbirth. The main questions it aims to answer are:

Is TMS a tolerable and acceptable treatment for postpartum women with OCD?

Does TMS improve OCD symptoms in postpartum women?

Does TMS change connectivity between areas of the brain involved in OCD?

Participants will:

  1. Receive 50 sessions of a type of TMS called continuous theta burst stimulation (cTBS) over the course of two weeks.
  2. Complete clinical assessments before and after TMS, as well as at 1 and 3 months post-treatment
  3. Undergo functional magnetic resonance imaging (fMRI) of the brain before and after TMS
Read the detailed description

This study will involve a small open-label, single arm feasibility trial of an accelerated cTBS protocol to the right orbitofrontal cortex (rOFC) in postpartum OCD. Following initial screening and consent, all participants (n=15) will undergo a baseline clinical assessment that will record OCD severity and symptom profiles, concurrent anxiety and depressive disorders, contraindications to TMS and medical history. Participants will then undergo a baseline functional magnetic resonance imaging (fMRI) scan at the Brown MRI Research Facility. This will be followed by 10 days of cTBS (5 sessions daily) to the rOFC during which symptoms and adverse effects will be monitored daily using a standardized checklist. At the end of day 5, participants will be asked to repeat some of the self-report clinical symptom measures included in the baseline clinical assessment. At the end of the cTBS protocol, participants will repeat a full clinical assessment, obtain an endpoint fMRI scan, and complete an acceptability questionnaire. Follow-up clinical assessments will be completed at 1-month and 3-months post-treatment either in person or virtually to assess the durability of responses. These data will be used as initial evidence of feasibility for a larger pilot study.

02

Conditions studied

  • Postpartum Obsessive Compulsive Disorder

Keywords

  • obsessive compulsive disorder
  • ocd
  • postpartum
  • peripartum
  • tms
  • transcranial magnetic stimulation
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-45
  2. Diagnosis of OCD defined by DSM-V criteria with problematic symptoms in the 12 months following childbirth
  3. YBOCS ≥16
  4. Either currently taking OCD medications at a stable dose for 8 weeks or unmedicated
  5. Concurrent psychotherapy (exposure and response prevention therapy) will be allowed if it was initiated 8 weeks or more before study entry and continues regularly throughout the trial
  6. Ability to read, write and understand English sufficiently well to complete study procedures and provide informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Past history of a primary psychotic or bipolar disorder
  2. Current acute suicidality or significantly elevated risk of suicide as determined by the investigators
  3. Personal history of moderate traumatic brain injury, epilepsy, or other clinically significant neurological illness except tic disorders
  4. A history of pre-eclampsia during the most recent pregnancy if the patient is less than 8 weeks postpartum
  5. Current, moderate to severe alcohol or illicit substance use disorder in the last 3 months, determined by clinical assessment
  6. Women who are currently pregnant. All participants will be asked to use a reasonable birth control method throughout the study period (barrier, oral contraceptives, etc.). We will not administer pregnancy tests.
  7. current psychotic symptoms
  8. A current seizure disorder
  9. active severe major depressive episode as indicated on the Edinburgh Postnatal Depression Scale (greater than or equal to 19).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Active Continuous Theta Burst Stimulation

    Participants will receive 50 total sessions of cTBS, administered as 5 sessions per day for 10 days. Each session will contain 1800 pulses.

    Device: Accelerated Continuous Theta Burst Stimulation (cTBS)

Interventions

  • DeviceAccelerated Continuous Theta Burst Stimulation (cTBS)

    Participants will receive 50 sessions of cTBS administered as 5 sessions per day over 10 days to the right orbitofrontal cortex. Each session will be 1800 pulses total.

05

What researchers measure

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (YBOCS)

    A 10-item scale that measures OCD symptom severity

    Time frame: From enrollment to the end of treatment at two weeks, and from enrollment to 1 and 3 months post-treatment.

Secondary outcomes

  1. The Edinburgh Postnatal Depression Scale (EPDS)

    A 10-item self-report measure of postnatal depression

    Time frame: From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment

  2. The Perinatal Anxiety Screening Scale (PASS)

    A 31-item self-report measure of perinatal anxiety symptoms

    Time frame: From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment

  3. The Generalized Anxiety Disorder-7 Scale (GAD-7)

    A 7-item self-report measure of anxiety

    Time frame: From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment

  4. Functional Connectivity on Magnetic Resonance Imaging (fMRI)

    Changes in functional connectivity between the right orbitofontal cortex and the broader "OCD connectome"

    Time frame: From enrollment to end of treatment at two weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes — All de-identified IPD collected throughout the trial may be shared with other researchers for the purposes of collaboration and publication.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT07571187
Lead sponsor
Butler Hospital
Responsible party
Sponsor
First posted
May 6, 2026
Start date
Apr 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
May 6, 2026

Study contacts

Meghan J. Kulak, MD
Contact
mkulak@kentri.org
401-680-4199
Meghan J. Kulak, MD
principal investigator · Butler Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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