Recruiting

BCSB & Therapy

Sponsor:

Reset Medical and Wellness Center

Code:

NCT07473505

Conditions

PTSD

Trauma-related Mental Health Symptoms

Moral Injury

Anxiety

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

stellate ganglion block with 0.5% ropivacaine

Study Details

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.

Conditions

PTSD

Trauma-related Mental Health Symptoms

Moral Injury

Anxiety

Traumatic Brain Injury

Study ID

NCT07473505

Start date

Mar 20, 2026

Status verified date

Mar, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Feb 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • PTSD Checklist for the DSM-5 [ Time Frame: From baseline to 7, 30, 60, 90, 180 and 270 days post BCSB procedure. ]

Central Contacts and Locations

Central contacts

Michael Louwers, MD

877-737-3810mlouwers@theresetcenter.com

Locations

Reset Medical and Wellness Center

Recruiting

Strongsville, Ohio, United States, 44136

Contacts

Michael Louwers

8777373810mlouwers@theresetcenter.com

More Information

Sponsor

Reset Medical and Wellness Center

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reset Medical and Wellness Center on 2026-03-20.