Accelerated Continuous Theta Burst Stimulation (cTBS)
DeviceParticipants 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.
NCT Number: NCT07571187
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
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to end of treatment at two weeks
Changes in functional connectivity between the right orbitofontal cortex and the broader "OCD connectome"
Contact information is provided by the study sponsor or research team.
Butler Hospital
Other
Continuous Theta Burst Treatment as a Novel Treatment for Postpartum Obsessive Compulsive Disorder
Acronym: Project MOM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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