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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 11, 2026

Last Update Submit

March 17, 2026

Conditions

PTSDTrauma-related Mental Health SymptomsMoral InjuryAnxietyTraumatic Brain Injury

Keywords

Bilateral Cervical Sympathetic BlocksStellate Ganglion BlockPTSDCombat VeteransPost Traumatic Stress DisorderSpecial Operations Forces VeteransTrauma Related SymptomsAnxietyMoral InjuryTraumatic Brain InjuryIntegrative TherapyMental Health

Outcome Measures

Primary Outcomes (1)

  • 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).

    From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure.

Secondary Outcomes (4)

  • 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.

Study Arms (1)

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.

Procedure: stellate ganglion block with 0.5% ropivacaine

Interventions

stellate ganglion block with 0.5% ropivacainePROCEDURE

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.

Also known as: 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
Ropivacaine Based BCSB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reset Medical and Wellness Center

Strongsville, Ohio, 44136, United States

RECRUITING

Related Publications (7)

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersBrain Injuries, TraumaticPsychological Well-Being

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Michael Louwers, MD

    Reset Medical and Wellness Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Louwers, MD

CONTACT

877-737-3810mlouwers@theresetcenter.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
270 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director and CEO Reset Medical and Wellness Center

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

February 24, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)