ACTIVE_NOT_RECRUITING

Stellate Ganglion Block for PTSD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-17
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05169190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans of any military branch
  2. * DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5)
  3. * at least moderate PTSD with a total CAPS-5 score of \> 26
  4. * having had at least one trial of an evidence-based treatment (EBT) for PTSD
  5. * subject report of engaging in the EBT (whether it be psycho- or pharmaco-therapy)
  6. * 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
  7. * 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
  8. * Eligible persons may have other symptoms that are commonly comorbid with PTSD (e.g., anxiety, moderate depression)
  9. * Severe primary depression will be an exclusion (see "Exclusion criteria" below)
  10. * This strategy will provide a feasible and generalizable sample
  11. * Women and minorities will be recruited
  1. * clear current and past six-months psychosis clearly not related to PSTD hypervigilance,
  2. * substance dependence (clear evidence of tolerance and/or withdrawal) within the past 6 months
  3. * 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))
  4. * decisional incapacity (e.g., dementia, clear evidence of testing that signifies incapacity to consent), OR Montreal Cognitive Assessment score \<18
  5. * centrally acting medications that have a potential effect on biological expression
  6. * pain levels requiring opiate medications
  7. * known exposure to chemicals or physical trauma that cause permanent neuropsychiatric sequelae
  8. * 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)
  9. * high risk of acute suicidality
  10. * 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
  11. * any witnessed apnea
  12. * feeling non-refreshed in the morning \>50% of mornings
  13. * daytime sleepiness indicated by falling asleep with routine tasks such as watching TV or reading
  14. * clear treatment non-adherence indicated by stopping treatment or \>3 missed appointments in the course of at least three PTSD EBTs
  15. * past clear and chronic PTSD prior to military service
  16. * current active psychotherapy for PTSD (they may suspend therapy if chosen by subject and therapist)
  17. * pregnancy
  18. * having had any prior SGB
  19. * unstable dose(s) of medication for depression, anxiety, PTSD, or for sleep, or any other psychoactive medication for 8-weeks prior to intervention
  20. * unwillingness to continue active medications at the same doses for the duration of the trial
  21. * 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

Contacts and Locations

Principal Investigator

Michael Hollifield, MD
PRINCIPAL_INVESTIGATOR
VA Long Beach Healthcare System, Long Beach, CA

Study Locations (Sites)

VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
United States
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05001-3833
United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Michael Hollifield, MD, PRINCIPAL_INVESTIGATOR, VA Long Beach Healthcare System, Long Beach, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-17
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-11-17
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Veterans
  • Trauma Disorders

Additional Relevant MeSH Terms

  • Post-traumatic Stress Disorder