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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meghan J. Kulak, MD | Contact | 401-680-4199 | mkulak@kentri.org |
| Name | Affiliation | Role |
|---|---|---|
| Meghan J. Kulak, MD | Butler Hospital | Principal Investigator |
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| Label | URL |
|---|---|
| The Study Website | View source |
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All de-identified IPD collected throughout the trial may be shared with other researchers for the purposes of collaboration and publication.
From enrollment with no end date
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.
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D003193 | Compulsive Personality Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010554 | Personality Disorders |
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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 |