Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- PTSD Checklist for the DSM-5
研究概览
简要总结
This study prospectively evaluates the effects of Integrative Bilateral Cervical Sympathetic Block (BCSB) on trauma-related symptoms in Special Operations Veterans, comparing outcomes in those receiving BCSB alone versus BCSB combined with structured integrative therapy. Using standardized FDA-approved dosing, validated symptom measures, and strict safety criteria, the study aims to determine whether this dual-level autonomic intervention improves PTSD-related and TBI-related symptoms, and whether pairing the procedure with therapy enhances durability and overall clinical benefit.
详细描述
This study is a prospective, observational case series designed to evaluate the clinical effects of integrative bilateral cervical sympathetic blocks (BCSB) on trauma-related symptoms in Special Operations Forces (SOF) veterans. The study is conducted through a collaboration between RESET Medical and Wellness Center, a clinical medical practice providing BCSB as part of routine care, and the Operator Relief Fund (ORF), a nonprofit organization that supports SOF veterans seeking treatment for posttraumatic stress and related symptoms.
Participants are adult Special Operations veterans who independently seek BCSB as a clinical intervention. Recruitment occurs through the natural intake flow of ORF. Individuals contacting ORF for support related to trauma symptoms are informed about the opportunity to participate in this research study during onboarding calls conducted by ORF staff. Participation in the study is voluntary and distinct from access to clinical care or ORF support services.
BCSB is a clinical procedure involving targeted sympathetic blockade at the cervical level, administered bilaterally, and is provided at RESET Medical and Wellness Center by licensed clinicians as part of standard medical care. The study does not alter the clinical indication, procedural technique, or clinical decision-making associated with BCSB. All clinical procedures are performed independent of research participation, and individuals may receive BCSB regardless of whether they enroll in the study.
The purpose of this study is to systematically collect longitudinal data on trauma-related psychological symptoms, functional outcomes, and safety indicators following BCSB in a real-world clinical population of SOF veterans. This prospective case series aims to contribute descriptive clinical data regarding symptom trajectories over time following the intervention. The current measures in this study include: PTSD Checklist for DSM-5, Generalized Anxiety Disorder-7, Moral Injury Symptom Scale - Military - Short Form, Adult Hope Scale, and the Neurobehavioral Symptom Inventory Scale.
After providing informed consent, participants complete baseline assessments prior to undergoing BCSB. Follow-up assessments are administered at 7, 30, 60, 90, 180 and 270 days following the procedure to evaluate changes in trauma-related symptoms and related functional domains. At the last survey on 270 days post procedure, they will also be invited to answer questions about how BCSB has effected their mind and bodies. Data collection is conducted remotely using secure electronic survey platforms. The study includes longitudinal follow-up for up to one year following the procedure, as specified in the protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •PTSD (PCL Score of 33 or greater at baseline screening)
- •Willing and able to provide informed consent and complete study procedures
- •Fluent in English
- •Special Operations Forces Veteran
排除标准
- •Recent Sympathetic Block: Receipt of any cervical sympathetic block (including stellate ganglion block [SGB], dual sympathetic ganglion block [DSGB], or bilateral SGB/BCSB), whether unilateral or bilateral, within the past 6 months.
- •Concurrent interventional clinical trial participation: Currently enrolled in another interventional clinical trial or receiving any experimental treatment targeting PTSD, TBI, or autonomic dysfunction during the study period
- •Acute Psychiatric Instability: Currently experiencing acute psychiatric crisis requiring inpatient care, active suicidal or homicidal intent, or untreated mania, psychosis, or severe dissociation
- •Medical Contraindications to BCSB: Any known anatomical abnormalities, bleeding disorders, allergy to local anesthetics, pregnancy, or comorbidities that represent a contraindication to receiving a cervical sympathetic block, per the treating physician's judgment.
- •Language or communication barriers: Inability to read, speak, or understand English sufficiently to complete informed consent and study assessments
- •Low PTSD Symptom Severity at Baseline: PCL-5 Score < 33 at screening, indicating subclinical or minimal PTSD symptoms (Rationale: to ensure measurable clinical benefit and reduce floor effects)
研究组 & 干预措施
Ropivacaine Based BCSB
This cohort consists of combat veterans participating in the RESET study to evaluate the effects of bilateral cervical sympathetic ganglion blocks (BCSB) on post-traumatic stress symptoms and suicide risk. Participants receive one procedures as a clinical intervention. Some participants may decided to access additional therapies, making BCSB an integrative model.
干预措施: stellate ganglion block with 0.5% ropivacaine (Procedure)
结局指标
主要结局
PTSD Checklist for the DSM-5
时间窗: From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.
In a military context, the PTSD Checklist for the DSM-5 (PCL-5) is one of the most commonly used psychological questionnaires. Derived from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the PCL-5 contains 20 self-report items assessing the degree to which individuals have been bothered by PTSD symptoms. Items are rated on a Likert scale ranging from 0 to 4. Individuals who score 33 or higher on the PCL-5 meet the cutoff commonly used to indicate PTSD. The PCL-5 has demonstrated internal consistency and validity in civilian populations, as well as in a study of service members (N = 12) (Wortmann et al., 2016).
次要结局
- General Anxiety Disorder - 7(From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.)
- Adult Hope Scale(From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.)
- Moral Injury Symptom Scale - Military Short Form(From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.)
- Neurobehavioral Symptom Inventory(From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.)
研究者
Michael Louwers
Medical Director and CEO Reset Medical and Wellness Center
Reset Medical and Wellness Center