Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07473505
Brief Summary:
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.
Detailed Description:
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.
The study collects self-reported psychological measures focused on trauma-related symptoms, as well as additional questionnaires addressing mental health, functional status, and quality-of-life domains, as outlined in the protocol. Clinical procedure data related to BCSB are also collected for research purposes and reporting of adverse events. No experimental manipulation, randomization, or control group is used in this study.
Safety monitoring is conducted through standard clinical care processes at RESET Medical and Wellness Center. Adverse events and serious adverse events are identified through clinical follow-up and participant self-report and are documented and reported in accordance with protocol-defined procedures. Oversight of human subjects protections, including continuing review and adverse event oversight, is provided by an independent institutional review board.
The Operator Relief Fund serves as a recruitment and participant support organization but is not the sponsor of the study and does not provide the clinical intervention. RESET Medical and Wellness Center is responsible for the delivery of the clinical procedure. Research data are collected and managed in compliance with applicable privacy and confidentiality protections, including the use of a study-specific HIPAA authorization.
Participation in the study does not provide financial compensation, nor does it alter the cost or availability of clinical care. Participants may withdraw from the study at any time without penalty or loss of access to clinical services or ORF support. If a participant withdraws, they may be asked to complete an optional survey regarding the reason for withdrawal.
This study is non-randomized, non-blinded, and descriptive in nature. The findings are intended to inform future research and contribute to the understanding of integrative bilateral cervical sympathetic blocks as a clinical intervention for trauma-related symptoms in Special Operations veteran populations.
Study:
NCT07473505
Study Brief:
Protocol Section:
NCT07473505