Continuous Theta Burst Treatment as a Novel Treatment for Postpartum Obsessive Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OCD defined by DSM-V criteria with problematic symptoms in the 12 months following childbirth
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Accelerated Continuous Theta Burst Stimulation (cTBS) (Device)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: 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
次要结局
- The Edinburgh Postnatal Depression Scale (EPDS)(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)(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)(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)(From enrollment to end of treatment at two weeks)