# Efficacy and Safety of Stellate Ganglion Block for Post-traumatic Stress Disorder in Veterans

> **NIH VA I01** · VETERANS HEALTH ADMINISTRATION · 2022 · —

## Abstract

Project Summary / Abstract (40 lines)
Stellate Ganglion Block (SGB) is a rapid-acting intervention that may directly target PTSD biology. Positive
case-studies and preliminary results from our team suggest clinically robust and significant benefits for up to 6-
months. Two randomized controlled trials, however, yielded conflicting results and had methodological
limitations, making interpretation of results inconclusive. Neither trial evaluated durability beyond 8-weeks,
safety, or biological mechanisms along with clinical outcomes. Veteran demand for SGB for PTSD is high,
creating time-sensitive urgency for a more definitive study in VA. We propose a 4-year, multi-site, two-phase,
three-arm, (SGB-experimental condition, Sham-placebo control, Wait-List Control (WLC)-for time, expectancy
and safety) parallel-group, triple-blind, prospective randomized controlled trial (RCT) of SGB for PTSD. The
sample will include 360 treatment-seeking Veterans with chronic PTSD randomized 1:1:1 to the three
treatment arms using an adaptive randomization procedure. Phase I is a 12-week RCT with the primary aims
of evaluating: a) within and between group differences in the change in PTSD symptom severity from pre- to 8-
weeks post-intervention, b) durability of symptom reduction after SGB over 12 weeks, and c) safety (i.e., SGB
will be as safe as Sham and WLC). Phase II is a 12-week open-label extension period where subjects in all
groups are offered active SGB if eligible (PTSD scores > inclusion criteria scores at the primary Phase I
endpoint of 8-weeks). Phase II is important because it allows evaluation of “enhanced dosing” (second SGB for
those in the SGB arm), it allows all subjects to receive active intervention if they want, which also provides a
larger sample of SGBs for exploratory pooled analyses, and it allows for analyses of durability over a longer
time period for those in remission after Phase I. Another secondary aim is to test the hypothesis that SGB will
be more biologically active than Sham or WLC by showing greater pre- to post-intervention reduction in highly
PTSD-relevant fear-potentiated startle. We will also explore clinical and biological predictors of an SGB
response (i.e., significant reduction in CAPS-5 scores). This superiority study is designed to expect and detect
statistically and clinically important 30% PTSD symptom reduction from baseline to 8-week endpoint for
SGB,15% reduction for Sham and 5% reduction for WLC in a sample with moderately severe PTSD (baseline
score of 65+18). With these assumptions we require a sample size of 262 subjects to test the primary
hypothesis of clinical efficacy. We will sample 360 subjects to account for 15% attrition, missing data, a 5%
failed-block rate and site variability. It is critical to ensure adequate power for this time-sensitive study.
Multivariate analysis of variance (MANOVA) will be used to test the null hypothesis of no differences in
baseline PTSD symptoms and subsequent retest of PTSD...

## Key facts

- **NIH application ID:** 10252644
- **Project number:** 1I01CX002333-01
- **Recipient organization:** VETERANS HEALTH ADMINISTRATION
- **Principal Investigator:** Charles Brock
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2022
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2022-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10252644

## Citation

> US National Institutes of Health, RePORTER application 10252644, Efficacy and Safety of Stellate Ganglion Block for Post-traumatic Stress Disorder in Veterans (1I01CX002333-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10252644. Licensed CC0.

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