Transcranial Magnetic Stimulation as a Treatment for Postpartum Obsessive Compulsive Disorder (Project MOM)

Continuous Theta Burst Treatment as a Novel Treatment for Postpartum Obsessive Compulsive Disorder

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Obsessive Compulsive Disorder
• Intervention / Treatment: Device: Accelerated Continuous Theta Burst Stimulation (cTBS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan J. Kulak, MD; Phone Number: 401-680-4199; Email: mkulak@kentri.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale-Brown Obsessive Compulsive Scale (YBOCS)	A 10-item scale that measures OCD symptom severity	From enrollment to the end of treatment at two weeks, and from enrollment to 1 and 3 months post-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Edinburgh Postnatal Depression Scale (EPDS)	A 10-item self-report measure of postnatal depression	From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment
The Perinatal Anxiety Screening Scale (PASS)	A 31-item self-report measure of perinatal anxiety symptoms	From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment
The Generalized Anxiety Disorder-7 Scale (GAD-7)	A 7-item self-report measure of anxiety	From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment
Functional Connectivity on Magnetic Resonance Imaging (fMRI)	Changes in functional connectivity between the right orbitofontal cortex and the broader "OCD connectome"	From enrollment to end of treatment at two weeks

Collaborators and Investigators

• Sponsor: Butler Hospital
• Investigators: Principal Investigator: Meghan J. Kulak, MD, Butler Hospital

Publications and helpful links

Helpful Links

• The Study Website

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: postpartum; transcranial magnetic stimulation; tms; obsessive compulsive disorder; ocd; peripartum
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2355278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified IPD collected throughout the trial may be shared with other researchers for the purposes of collaboration and publication.
• IPD Sharing Time Frame: From enrollment with no end date
• IPD Sharing Access Criteria: IPD will only be shared upon request and at the discretion of the principal investigator solely for the purposes of collaboration, analysis, or publication. All shared IPD will be de-identified.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No