NCT07473505 · Reset Medical and Wellness Center
Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
stellate ganglion block with 0.5% ropivacaine
This 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.
Primary outcome measures
PTSD Checklist for the DSM-5
Time frame: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
Where
- Strongsville, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations