About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
This study will include adult Special Operations Forces (SOF) veterans with PTSD who meet eligibility criteria who are through the Operator Relief Fund network of care. Individuals with post-traumatic stress disorder (PTSD) are considered a vulnerable population due to potential emotional sensitivity and risk of psychological distress. Because of this, additional safeguards will be used during recruitment and enrollment to prevent coercion, protect autonomy, and support participant well-being. These safeguards include the use of neutral recruitment language, IRB-approved scripts, and clear communication that participation is entirely voluntary. This study will not discriminate based on race, ethnicity, national origin, gender, sexual orientation, religion, marital status, disability, or socioeconomic status. All eligible individuals will be given equal opportunity to participate.
Trial design
Other
Prospective
Treatments tested in this trial
stellate ganglion block with 0.5% ropivacaine
Procedure/SurgeryThis study is distinct because it evaluates an integrative, dual-level bilateral cervical sympathetic block (BCSB), a more comprehensive autonomic intervention than the traditional unilateral SGB, specifically in Special Operations Veterans, a uniquely high-trauma, high-TBI population rarely studied. It is also the first to directly compare BCSB alone versus BCSB combined with structured integrative psychological therapy, using a prospective design with validated outcome measures, strict inclusion/exclusion criteria, and standardized FDA-approved dosing. By incorporating TBI-specific symptom tracking and applying IND-level rigor in a specialized trauma-informed clinical setting, this study fills critical gaps left by prior SGB research and offers a clearer understanding of who benefits most and why.
Treatment groups
Trial outcomes
Primary outcomes
PTSD Checklist for the DSM-5
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).
Secondary outcomes
General Anxiety Disorder - 7
Often used by the Veterans Health Administration, the Generalized Anxiety Disorder-7 (GAD-7) is a brief self-report measure designed to assess the severity of generalized anxiety disorder. The GAD-7 consists of seven items assessing anxiety symptoms and their severity over the past two weeks. The GAD-7 has been shown to be internally consistent and valid for use in both civilian and veteran populations (Ahmadi et al., 2023).
Adult Hope Scale
Created in 1991, the Adult Hope Scale (AHS) is based on the theory that hope plays a crucial role in an individual's overall well-being. The AHS contains 12 items that assess an individual's motivation to achieve goals as well as their perceived ability to develop strategies to meet those goals. The AHS is a well-established measure and has demonstrated reliability (Labrosciano et al., 2025).
Moral Injury Symptom Scale - Military Short Form
Developed by Koenig et al. (2018), the Moral Injury Symptom Scale - Military Short Form (MISS-M-SF) is a shortened military-specific version of the original Moral Injury Symptom Scale designed for use in active-duty and veteran populations. Moral injury is a subset of trauma related to moral, spiritual, and religious distress arising from events involving ethical conflict. Such events may include witnessing or causing violence, dehumanizing others, or observing leaders or peers violate moral beliefs. A common example of moral injury is guilt related to surviving an event in which others were injured or killed. The short-form version was created using the highest factor-loading items from the original scale. These 10 items assess domains including betrayal of leaders, guilt, shame, trust, meaning, forgiveness, failure, and religious struggles. The MISS-M-SF has demonstrated high reliability and validity (Koenig et al., 2018).
Neurobehavioral Symptom Inventory
There is a 28% chance that a military service member will experience TBI (Mulvaney et al., 2024). For the majority (80%) of these troops, their TBI is blast exposure related, often causing cerebral edema and vasospasm (Lindberg et al., 2022). TBI is also associated with chronic traumatic encephalopathy and Alzheimer's disease over time. For individuals with TBI, there is a 43.9% likelihood of also experiencing PTSD. Practitioners began to notice that patients who had PTSD/TBI were reporting decreased headaches and brain fog after BCSB (Mulvaney et al., 2024). The NSI is the scaled used at the Department of Veterans Affairs (VA) if they have previously screened positive for TBI (Ashendorf, 2019).
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