Stellate Ganglion Block for PTSD

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Post-traumatic Stress Disorder

In brief

Posttraumatic Stress Disorder (PTSD) is a debilitating condition that affects about 15% of Veterans. Current treatments for Veterans with PTSD include medications and psychological therapies that help to process and desensitize to traumatic events. While effective for many, these treatments do not work for all patients, and many may refuse them. Stellate Ganglion Block (SGB), established to treat pain and other conditions, has shown promise for PTSD: early small studies show it may work fast and greatly reduce symptoms. However, data from larger studies are not clear about SGBs effects. A definitive trial is needed, especially for the Veteran population. This large, well-powered, randomized, sham-controlled trial of SGB for PTSD will assess the short-term efficacy of this intervention, the durability of the effects and the safety of the treatment. Additionally, this study will provide critically important information about biological effects of SGB and potential mechanisms of action. This timely study is critical to help VA clinicians better decide about the merits of SGB for PTSD.

Key facts

Study ID

NCT05169190

Run by

VA Office of Research and Development

People needed

410

Starts

2022-11-17

Expected to finish

2026-06-30

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
• James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont, United States
• William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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