Using Stellate Ganglion Block to treat PTSD in Veterans
Efficacy and Safety of Stellate Ganglion Block for Post-traumatic Stress Disorder in Veterans
This study is testing if a special injection called Stellate Ganglion Block can help veterans with chronic PTSD feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 6 sites (Long Beach, California and 5 other locations) |
| Trial ID | NCT05169190 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Stellate Ganglion Block (SGB) as a treatment for chronic Post-Traumatic Stress Disorder (PTSD) in Veterans. The study will involve 360 participants who will be randomly assigned to receive either the SGB intervention, a sham procedure, or be placed on a wait-list control. The trial aims to evaluate the short-term efficacy, durability of symptom reduction, and safety of SGB over a 12-week period. Additionally, it will explore the biological effects and potential mechanisms of action associated with SGB treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans diagnosed with chronic PTSD who have previously tried at least one evidence-based treatment.
Not a fit: Patients with severe primary depression or those who have not engaged in any evidence-based treatment for PTSD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide rapid and significant relief from PTSD symptoms for Veterans who have not responded to traditional therapies.
How similar studies have performed: While some early studies have shown promise for SGB in treating PTSD, larger studies have yielded conflicting results, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veterans of any military branch * DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5) * at least moderate PTSD with a total CAPS-5 score of \> 26 * having had at least one trial of an evidence-based treatment (EBT) for PTSD Verification of an EBT trial will be by: * subject report of engaging in the EBT (whether it be psycho- or pharmaco-therapy) * CPRS or other medical record system (if outside VA) verification to determine that the dose and time (applies to both meds and therapy) was an adequate trial OR that they clearly did not finish the EBT due to clear aversion * They will be eligible if they did not finish the EBT due to aversion, but they must have had a trial and be fully informed during informed consent for this study of the available clinical treatment options * Eligible persons may have other symptoms that are commonly comorbid with PTSD (e.g., anxiety, moderate depression) * Severe primary depression will be an exclusion (see "Exclusion criteria" below) * This strategy will provide a feasible and generalizable sample * Women and minorities will be recruited Exclusion Criteria: * clear current and past six-months psychosis clearly not related to PSTD hypervigilance, * substance dependence (clear evidence of tolerance and/or withdrawal) within the past 6 months * thyroid disease and other contraindications to SGB (anatomic abnormalities of the anterior cervical spine; cardiac/pulmonary compromise; acute illness/infection; coagulopathy/bleeding disorder; allergic reactions/contraindications to local anesthetic or contrast dye, prior anterior neck surgery, anterior neck skin abnormalities (rash or eruptions)) * decisional incapacity (e.g., dementia, clear evidence of testing that signifies incapacity to consent), OR Montreal Cognitive Assessment score \<18 * centrally acting medications that have a potential effect on biological expression * pain levels requiring opiate medications * known exposure to chemicals or physical trauma that cause permanent neuropsychiatric sequelae * severe depression (Quick Inventory of Depression-SR16 (QIDS-SR16 score \>18) that is deemed more clinically significant than PTSD (i.e., depression, cluster D PTSD, and minimal symptoms from cluster B, C, and E) * high risk of acute suicidality * a diagnosed and untreated moderate or severe sleep breathing disorder (SBD), OR a high risk of a SBD as indicated by snoring \>50% of nights plus one of * any witnessed apnea * feeling non-refreshed in the morning \>50% of mornings * daytime sleepiness indicated by falling asleep with routine tasks such as watching TV or reading * clear treatment non-adherence indicated by stopping treatment or \>3 missed appointments in the course of at least three PTSD EBTs * past clear and chronic PTSD prior to military service * current active psychotherapy for PTSD (they may suspend therapy if chosen by subject and therapist) * pregnancy * having had any prior SGB * unstable dose(s) of medication for depression, anxiety, PTSD, or for sleep, or any other psychoactive medication for 8-weeks prior to intervention * unwillingness to continue active medications at the same doses for the duration of the trial * a person who is on a stable medication dose for \> 8 weeks who meets inclusion criteria and will continue these medications for the trial duration will not be excluded
Where this trial is running
Long Beach, California and 5 other locations
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (Recruiting)
- James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States (Recruiting)
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (Recruiting)
- White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont, United States (Recruiting)
- William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Michael Hollifield, MD — VA Long Beach Healthcare System, Long Beach, CA
- Study coordinator: Michael Alkire, MD
- Email: michael.alkire@va.gov
- Phone: (562) 826-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.