Transcranial Magnetic Stimulation as a Treatment for Postpartum Obsessive Compulsive Disorder

NCT07571187 | Not Yet Recruiting

• 1 other identifier: 2355278
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Conditions

Postpartum Obsessive Compulsive Disorder

Keywords

obsessive compulsive disorder; ocd; postpartum; peripartum; tms; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Edinburgh Postnatal Depression Scale (EPDS)

  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)

  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)

  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)

  From enrollment to end of treatment at two weeks

Study Arms (1)

Active Continuous Theta Burst Stimulation

EXPERIMENTAL

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

Accelerated Continuous Theta Burst Stimulation (cTBS) DEVICE

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.

Active Continuous Theta Burst Stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45
• Diagnosis of OCD defined by DSM-V criteria with problematic symptoms in the 12 months following childbirth
• YBOCS ≥16
• Either currently taking OCD medications at a stable dose for 8 weeks or unmedicated
• 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
• Ability to read, write and understand English sufficiently well to complete study procedures and provide informed consent.

You may not qualify if:

• Past history of a primary psychotic or bipolar disorder
• Current acute suicidality or significantly elevated risk of suicide as determined by the investigators
• Personal history of moderate traumatic brain injury, epilepsy, or other clinically significant neurological illness except tic disorders
• A history of pre-eclampsia during the most recent pregnancy if the patient is less than 8 weeks postpartum
• Current, moderate to severe alcohol or illicit substance use disorder in the last 3 months, determined by clinical assessment
• 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.
• current psychotic symptoms
• A current seizure disorder
• active severe major depressive episode as indicated on the Edinburgh Postnatal Depression Scale (greater than or equal to 19).

Sponsors & Collaborators

• Butler Hospital: lead

Related Links

• The Study Website

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Compulsive Personality Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Personality Disorders

Study Officials

• Meghan J. Kulak, MD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan J. Kulak, MD

CONTACT

401-680-4199; mkulak@kentri.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From enrollment with no end date
• 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.