Transcranial Magnetic Stimulation as a Treatment for Postpartum Obsessive Compulsive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorButler Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Active Continuous Theta Burst StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Yale-Brown Obsessive Compulsive Scale (YBOCS)
A 10-item scale that measures OCD symptom severity
Time frame
From enrollment to the end of treatment at two weeks, and from enrollment to 1 and 3 months post-treatment.Secondary outcomes
1
The Edinburgh Postnatal Depression Scale (EPDS)
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-treatment2
The Perinatal Anxiety Screening Scale (PASS)
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-treatment3
The Generalized Anxiety Disorder-7 Scale (GAD-7)
A 7-item self-report measure of anxiety
Time frame
From enrollment to end of treatment at 2 weeks, and from enrollment to 1 and 3 months post-treatment4
Functional Connectivity on Magnetic Resonance Imaging (fMRI)
Changes in functional connectivity between the right orbitofontal cortex and the broader "OCD connectome"
Time frame
From enrollment to end of treatment at two weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: