Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 4:09 AM
Study NCT ID:
NCT07473505
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'targetDuration': '270 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist for the DSM-5', 'timeFrame': 'From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'General Anxiety Disorder - 7', 'timeFrame': 'From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.', 'description': '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).'}, {'measure': 'Adult Hope Scale', 'timeFrame': 'From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.', 'description': "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)."}, {'measure': 'Moral Injury Symptom Scale - Military Short Form', 'timeFrame': 'From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.', 'description': '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).'}, {'measure': 'Neurobehavioral Symptom Inventory', 'timeFrame': 'From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.', 'description': "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)."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bilateral Cervical Sympathetic Blocks', 'Stellate Ganglion Block', 'PTSD', 'Combat Veterans', 'Post Traumatic Stress Disorder', 'Special Operations Forces Veterans', 'Trauma Related Symptoms', 'Anxiety', 'Moral Injury', 'Traumatic Brain Injury', 'Integrative Therapy', 'Mental Health'], 'conditions': ['PTSD', 'Trauma-related Mental Health Symptoms', 'Moral Injury', 'Anxiety', 'Traumatic Brain Injury']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Wortmann, J. H., Jordan, A. H., Weathers, F. W., Resick, P. A., Dondanville, K. A., Hall-Clark, B., Foa, E. B., Young-McCaughan, S., Yarvis, J. S., Hembree, E. A., Mintz, J., Peterson, A. L., & Litz, B. T. (2016). Psychometric Analysis of the PTSD Checklist-5 (PCL-5) Among Treatment-Seeking Military Service Members. Psychological Assessment, 28(11), 1392-1403. https://doi.org/10.1037/pas0000260'}, {'type': 'BACKGROUND', 'citation': 'Lindberg, M. A., Moy Martin, E. M., & Marion, D. W. (2022). Military Traumatic Brain Injury: The History, Impact, and Future. Journal of neurotrauma, 39(17-18), 1133-1145. https://doi.org/10.1089/neu.2022.0103'}, {'type': 'BACKGROUND', 'citation': 'Labrosciano, K., Dorrian, J., Lowies, B., Russell, R., & Lushington, K. (2025). Adult Hope Scale: validation in older adults. Australian journal of psychology, 77(1), 2532077. https://doi.org/10.1080/00049530.2025.2532077'}, {'type': 'BACKGROUND', 'citation': "Koenig, H. G., Ames, D., Youssef, N. A., Oliver, J. P., Volk, F., Teng, E. J., Haynes, K., Erickson, Z. D., Arnold, I., O'Garo, K., & Pearce, M. (2018). Screening for Moral Injury: The Moral Injury Symptom Scale - Military Version Short Form. Military Medicine, 183(11-12), e659-e665. https://doi.org/10.1093/milmed/usy017"}, {'type': 'BACKGROUND', 'citation': 'Ashendorf, L. (2019). Neurobehavioral symptom validity in U.S. Department of Veterans Affairs (VA) mild traumatic brain injury evaluations. Journal of Clinical and Experimental Neuropsychology, 41(4), 432-441. https://doi.org/10.1080/13803395.2019.1567693'}, {'type': 'BACKGROUND', 'citation': 'Ahmadi, A., Ponder, W. N., Carbajal, J., Schuman, D. L., Whitworth, J., Yockey, R. A., & Galusha, J. M. (2023). Validation of the PCL-5, PHQ-9, and GAD-7 in a Sample of Veterans. Journal of occupational and environmental medicine, 65(8), 643-654. https://doi.org/10.1097/JOM.0000000000002898'}, {'type': 'RESULT', 'citation': 'Mulvaney, S. W., Lynch, J. H., Mahadevan, S., Dineen, K. J., & Rae Olmsted, K. L. (2024). The effect of bilateral, two-level cervical sympathetic chain blocks on specific symptom clusters for traumatic brain injury, independent of concomitant PTSD symptoms. Brain Sciences, 14(12), 1193. https://doi.org/10.3390/brainsci14121193'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants 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.\n\nBCSB 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.\n\nThe 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.\n\nAfter 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.\n\nThe 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.\n\nSafety 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.\n\nThe 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.\n\nParticipation 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* PTSD (PCL Score of 33 or greater at baseline screening)\n* Willing and able to provide informed consent and complete study procedures\n* Fluent in English\n* Special Operations Forces Veteran\n\nExclusion Criteria:\n\n* 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.\n* 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\n* Acute Psychiatric Instability: Currently experiencing acute psychiatric crisis requiring inpatient care, active suicidal or homicidal intent, or untreated mania, psychosis, or severe dissociation\n* 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.\n* Language or communication barriers: Inability to read, speak, or understand English sufficiently to complete informed consent and study assessments\n* 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)"}, 'identificationModule': {'nctId': 'NCT07473505', 'briefTitle': 'Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series', 'organization': {'class': 'OTHER', 'fullName': 'Reset Medical and Wellness Center'}, 'officialTitle': 'Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series.', 'orgStudyIdInfo': {'id': 'Pro00091559'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ropivacaine Based BCSB', 'description': '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.', 'interventionNames': ['Procedure: stellate ganglion block with 0.5% ropivacaine']}], 'interventions': [{'name': 'stellate ganglion block with 0.5% ropivacaine', 'type': 'PROCEDURE', 'otherNames': ['Cervical Sympathetic Block', 'Dual Level Cervical Sympathetic Block', 'Dual Level Stellate Ganglion Block', 'SGB', 'DCSB', 'Bilateral Cervical Sympathetic Block', 'DSGB', 'ASGB', 'Advanced Stellate Ganglion Block'], 'description': '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.', 'armGroupLabels': ['Ropivacaine Based BCSB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44136', 'city': 'Strongsville', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Louwers', 'role': 'CONTACT', 'email': 'mlouwers@theresetcenter.com', 'phone': '8777373810'}], 'facility': 'Reset Medical and Wellness Center', 'geoPoint': {'lat': 41.3145, 'lon': -81.83569}}], 'centralContacts': [{'name': 'Michael Louwers, MD', 'role': 'CONTACT', 'email': 'mlouwers@theresetcenter.com', 'phone': '877-737-3810'}], 'overallOfficials': [{'name': 'Michael Louwers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reset Medical and Wellness Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "The study team has elected not to share individual participant data, including deidentified datasets. This decision is based on ethical and methodological considerations specific to the study population and design. Participants are Special Operations Forces veterans, a population for whom concerns about privacy, stigma, and downstream use of sensitive mental health data may negatively affect willingness to participate. Additionally, given the observational case series design, small sample size, and context-dependent clinical variables, secondary analyses by external parties could result in misinterpretation or inappropriate conclusions that do not reflect the study's intent or limitations. Aggregate results and summary-level findings will be reported publicly through ClinicalTrials.gov and peer-reviewed publications to support transparency while prioritizing participant trust and data integrity."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reset Medical and Wellness Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director and CEO Reset Medical and Wellness Center', 'investigatorFullName': 'Michael Louwers', 'investigatorAffiliation': 'Reset Medical and Wellness Center'}}}}