A Randomized, Double Blind, Placebo-controlled Study of the Effects of Stellate Ganglion Block on Neural Activity and Symptoms in Participants With Post-traumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Change in Skin Conductance Response (SCR) Amount
研究概览
简要总结
This study will enroll patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for post-traumatic stress disorder (PTSD). Following an initial screening visit, clinical assessment, and enrollment, subjects will be randomized into treatment and placebo arms. Both cohorts will undergo a pre-intervention functional magnetic resonance imaging (fMRI) of their brain. Treatment subjects will receive unilateral two-level stellate ganglion block via ultrasound-guided injection of anesthetic (bupivacaine) into the cervical sympathetic tissue; placebo subjects will receive an identical volume of saline via the same procedures.
At approximately 4 weeks post-procedure, both cohorts will then undergo a post-intervention clinical assessment. Finally, both cohorts will undergo a post-intervention fMRI of their brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •Chronic (at least one month post-trauma) DSM-5 PTSD symptoms
- •CAPS-5 Past Month score ≥ 26
- •Meets current DSM-5 PTSD diagnosis
- •Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines)
- •Willing and able to provide informed consent
排除标准
- •History of stellate ganglion block treatment
- •Allergy to local anesthetics (e.g. ropivacaine, bupivacaine)
- •Allergy to iodinated contrast agents
- •Diagnosis of bipolar I disorder with a past year manic episode
- •Diagnosis of a psychotic disorder or psychotic symptoms
- •Diagnosis of current moderate or severe substance use disorder
- •History of neurological disease (that involves the brain), seizure, or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion)
- •Significant recent suicidal ideation or significant suicidal behavior in the past 12 months or suicidal ideation with imminent risk that warrants a higher level of care
- •Concurrent trauma focused psychotherapy
- •Pregnancy (to be ruled out by urine ß-HCG)
- •Metallic implants or devices contraindicating magnetic resonance imaging by interfering with patient safety or fMRI data collection; cases will be cleared by the Principal Investigator and Center for Brain Imaging
- •Morbid obesity (BMI >4 kg/m2)
- •Current use of opioids, cocaine, or benzodiazepines (as assessed by urine toxicology)
- •Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily.
- •Cardiac conditions or any prior heart surgeries
- •Respiratory conditions such as COPD or untreated asthma
- •History of heavy metal poisoning
- •History of neck or throat surgeries
- •Vocal cord problems or paralysis
- •Untreated high blood pressure
- •Current cancer diagnosis
- •Diagnosis of Guillain-Barré syndrome
- •Diagnosis of Parkinson's Disease
- •Unable to take 7 days off of blood thinners
研究组 & 干预措施
Control Group
干预措施: Saline (Drug)
Stellate Ganglion Block (SGB) Group
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Change in Skin Conductance Response (SCR) Amount
时间窗: Week 2, Week 8
SCR will be reported as the number of sweat glads that are activated. The more emotionally aroused an individual is, the more the SCR amount is increased. SCR will be measured during three related viewing, learning, and choice tasks, quantified as the changes between the pre-intervention fMRI scan (visit 2) and the post-intervention fMRI scan (visit 5).
Change in Cerebral Blood Flow Levels
时间窗: Week 2, Week 8
Blood flow levels will be obtained from Blood Oxygen Level Dependent (BOLD) fMRI signals during three related viewing, learning, and choice tasks, quantified as the changes between the pre-intervention fMRI scan (visit 2) and the post-intervention fMRI scan (visit 5).
次要结局
- Posttraumatic Stress Disorder Checklist (PCL-5) Score(Week 15)
- Patient Health Questionnaire-9 (PHQ-9) Score(Week 15)
- State-Trait Anxiety Inventory (STAI) - Form Y1 Score(Week 15)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) Score(Week 15)
- Posttraumatic Stress Disorder Checklist (PCL-5) Score(Week 1)
- Posttraumatic Stress Disorder Checklist (PCL-5) Score(Week 7)
- Patient Health Questionnaire-9 (PHQ-9) Score(Week 1)
- Patient Health Questionnaire-9 (PHQ-9) Score(Week 7)
- State-Trait Anxiety Inventory (STAI) - Form Y1 Score(Week 1)
- State-Trait Anxiety Inventory (STAI) - Form Y1 Score(Week 7)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) Score(Week 1)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) Score(Week 7)