Postpartum Obsessive Compulsive DisorderProject MOMNCT07571187
Transcranial Magnetic Stimulation as a Treatment for Postpartum Obsessive Compulsive Disorder
A study testing Accelerated Continuous Theta Burst Stimulation (cTBS) in people with Postpartum Obsessive Compulsive Disorder, run by Butler Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Obsessive Compulsive Disorder
- What is being tested?
- Accelerated Continuous Theta Burst Stimulation (cTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
Does TMS improve OCD symptoms in postpartum women?
Does TMS change connectivity between areas of the brain involved in OCD?
Participants will:
- Receive 50 sessions of a type of TMS called continuous theta burst stimulation (cTBS) over the course of two weeks.
- Complete clinical assessments before and after TMS, as well as at 1 and 3 months post-treatment
- 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.
- Conditions
- Postpartum Obsessive Compulsive Disorder
- Being tested
- Accelerated Continuous Theta Burst Stimulation (cTBS)
- Keywords
- obsessive compulsive disorder, ocd, postpartum, peripartum, tms, transcranial magnetic stimulation
- Medical subject headings
- Obsessive-Compulsive Disorder, Compulsive Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accelerated Continuous Theta Burst Stimulation (cTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (YBOCS)
A 10-item scale that measures OCD symptom severity
Measured: 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)
A 10-item self-report measure of postnatal depression
Measured: 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
Measured: 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
Measured: 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"
Measured: From enrollment to end of treatment at two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startApr 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan J. Kulak, MD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571187
- Sponsor's protocol ID
- 2355278
- Acronym
- Project MOM
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD collected throughout the trial may be shared with other researchers for the purposes of collaboration and publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Theta Burst Treatment as a Novel Treatment for Postpartum Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT07571187
- Acronym / sponsor ID
- Project MOM / 2355278
- Conditions
- Postpartum Obsessive Compulsive Disorder
- Keywords
- obsessive compulsive disorder, ocd, postpartum, peripartum, tms, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Receive 50 sessions of a type of TMS called continuous theta burst stimulation (cTBS) over the course of two weeks.
- Complete clinical assessments before and after TMS, as well as at 1 and 3 months post-treatment
- Undergo functional magnetic resonance imaging (fMRI) of the brain before and after TMS
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Continuous Theta Burst Stimulation | Experimental | Device: Accelerated Continuous Theta Burst Stimulation (cTBS)Participants will receive 50 total sessions of cTBS, administered as 5 sessions per day for 10 days. Each session will contain 1800 pulses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active Continuous Theta Burst Stimulation |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: From enrollment to the end of treatment at two weeks, and from enrollment to 1 and 3 months post-treatment.
A 10-item scale that measures OCD symptom severity
4 secondary outcomes
The Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From enrollment to end of treatment at two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- The Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All de-identified IPD collected throughout the trial may be shared with other researchers for the purposes of collaboration and publication.
Related trials for Postpartum Obsessive Compulsive Disorder
RecruitingObservational study
Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools in the Perinatal Period.
Depressive; Episode, Major, Depression, Postpartum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meghan J. Kulak, MD principal investigator
Butler Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Continuous Theta Burst Stimulation (cTBS) in people with Postpartum Obsessive Compulsive Disorder, run by Butler Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghan J. Kulak, MD (401-680-4199, mkulak@kentri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Scale (YBOCS) (time frame: From enrollment to the end of treatment at two weeks, and from enrollment to 1 and 3 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.