Transcranial Magnetic Stimulation as a Treatment for Postpartum Obsessive Compulsive Disorder (Project MOM)
30 de abril de 2026 actualizado por: Butler Hospital
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:
- 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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
15
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Meghan J. Kulak, MD
- Número de teléfono: 401-680-4199
- Correo electrónico: mkulak@kentri.org
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Periodo de tiempo: 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
|
From enrollment to the end of treatment at two weeks, and from enrollment to 1 and 3 months post-treatment.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Edinburgh Postnatal Depression Scale (EPDS)
Periodo de tiempo: From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment
|
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)
Periodo de tiempo: From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment
|
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)
Periodo de tiempo: From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment
|
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)
Periodo de tiempo: From enrollment to end of treatment at two weeks
|
Changes in functional connectivity between the right orbitofontal cortex and the broader "OCD connectome"
|
From enrollment to end of treatment at two weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Meghan J. Kulak, MD, Butler Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de abril de 2026
Finalización primaria (Estimado)
1 de enero de 2028
Finalización del estudio (Estimado)
1 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de abril de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2355278
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All de-identified IPD collected throughout the trial may be shared with other researchers for the purposes of collaboration and publication.
Marco de tiempo para compartir IPD
From enrollment with no end date
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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