Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

30. april 2026 opdateret af: 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:

  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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Edinburgh Postnatal Depression Scale (EPDS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Butler Hospital

Efterforskere

  • Ledende efterforsker: Meghan J. Kulak, MD, Butler Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2355278

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All de-identified IPD collected throughout the trial may be shared with other researchers for the purposes of collaboration and publication.

IPD-delingstidsramme

From enrollment with no end date

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner