Stellate Ganglion Block for PTSD

NCT05169190 | Active Not Recruiting DMC

• 1 other identifier: MHBP-006-20F
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Post-traumatic Stress Disorder

Keywords

Veterans; Trauma Disorders

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale-5

  The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured diagnostic interview for PTSD. CAPS-5 items are rated with a single severity score, in contrast to previous versions of the CAPS which required separate frequency and intensity scores for each item that were either summed to create a symptom severity score or combined in various scoring rules to create a dichotomous (present/absent) symptom score. CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe). There are 4 symptom clusters and DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria. A CAPS-5 cutoff score of \>26 will be used for study inclusion.

  8 weeks after SGB, Sham, or WLC enrollment

• Safety - Adverse Events and Side Effects from Treatment

  The Systematic Assessment for Treatment Emergent Events (SAFTEE) (Levine \& Schooler, 1986) was developed at NIH and has been used in numerous clinical trials to track and compare adverse events and side-effects from pre- to post-intervention and between interventions. There is more than one version length. The investigators will use the 55-item version that has a baseline form and a "since last visit" form to comprehensively evaluate emergent symptoms in multiple body systems and compare pre- to post-intervention in a time X intervention approach.

  8 weeks after SGB, Sham, or WLC enrollment

Secondary Outcomes (1)

• Peripheral Psychophysiology Startle Response

  8 weeks after SGB, Sham, or WLC enrollment

Study Arms (3)

SGB

ACTIVE COMPARATOR

SGB, the experimental procedure, is the injection of 7 cc of 0.5% ropivacaine plus 0.5 cc contrast anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle

Procedure: Stellate Ganglion Block

Sham

SHAM COMPARATOR

Sham, the placebo control group, is the injection of 7 cc of normal saline plus 0.5 cc contrast anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle

Procedure: Sham Stellate Ganglion Block

Wait-List Control (WLC)

NO INTERVENTION

WLC, a control for time, expectancy and safety, is all study procedures without going to the procedure room for injection

Interventions

Stellate Ganglion Block PROCEDURE

After procedure informed consent, the procedure will be done using an ultrasound guided technique with a high frequency (6 to 13 MHz) linear transducer and confirmation of placement by fluoroscopy at sites who do this in clinical practice. The subject will be prepped and draped and placed in supine position in a suite with continuous vital sign monitoring and advanced cardiac life support equipment and IV placement. Local anesthesia with 1% buffered lidocaine will be achieved. After visualization of Chassaignac's tubercle of C6 is identified along with the carotid artery, internal jugular vein and longus colli and capitus muscles, a 25-gauge echo-enhanced needle will be inserted to inject anesthetic over 2 minutes anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle. The needle will be withdrawn and the subject will be monitored for a minimum of 30 minutes.

Also known as: SGB or Regional Block

SGB

Sham Stellate Ganglion Block PROCEDURE

The Sham protocol is identical to the SGB protocol except "After needle tip confirmation and negative aspiration, normal saline (0.9%) + contrast (unlabeled to keep treater blinded) will be slowly injected over 2 minutes while closely monitoring the subject."

Also known as: Sham SGB

Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

You may not qualify if:

• This strategy will provide a feasible and generalizable sample
• Women and minorities will be recruited
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Analydata, Inc.: collaborator

Study Sites (6)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05001-3833, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

Related Publications (1)

• Hollifield M, Brock C, Lim K, Holtzheimer P, Alkire M, Macedo F, Bovin MJ, Smith T, Romesser J, Messina M, Jovanovic T, Norrholm S, Krajec A. Efficacy and safety of the stellate ganglion block for posttraumatic stress disorder in veterans: Rationale for and methods of a multisite trial. Contemp Clin Trials. 2026 Jan;160:108180. doi: 10.1016/j.cct.2025.108180. Epub 2025 Dec 4.

  PMID: 41352532 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Michael Hollifield, MD

  VA Long Beach Healthcare System, Long Beach, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All assessments will be conducted by the Site Coordinator (SC) and clinical assessors at each time point blind to group allocation. The SGB assessor will conduct the Horner's syndrome evaluation after the procedure and will only share the results with data entry personnel. The primary data base in REDCap will show SID# only to keep the SC blinded while entering data. The minim program will assign each subject a Treatment ID number by site (e.g., TID# LB1S to LB20S for SGB at Long Beach site) and consecutive study ID numbers (e.g., SID# LB1 - LB90), which will be the only number on hard copies of documents in order to conceal allocation from all staff. The statisticians will be the only staff that will be able to link both SID and TID numbers to subject. The research pharmacy preparing the syringes will of course have both ID numbers and will label the syringes with only the SID#, keeping all personnel blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a two-phase, three-arm (SGB vs Sham vs Wait List Control (WLC)), parallel-group (n=120 in each), triple-blind, prospective randomized controlled clinical trial (RCT). Phase I is 12-weeks and is the primary three-group RCT. Phase II is a 12-week open-label extension period where subjects in all groups are offered active SGB if eligible, defined as having PTSD scores \> study inclusion criteria scores at the Phase I endpoints.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 23, 2021
• Study Start: November 17, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)