RECRUITING

Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

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Conditions

Post Traumatic Stress Disorder

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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

This study will enroll patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for post-traumatic stress disorder (PTSD). Following an initial screening visit, clinical assessment, and enrollment, subjects will be randomized into treatment and placebo arms. Both cohorts will undergo a pre-intervention functional magnetic resonance imaging (fMRI) of their brain. Treatment subjects will receive unilateral two-level stellate ganglion block via ultrasound-guided injection of anesthetic (bupivacaine) into the cervical sympathetic tissue; placebo subjects will receive an identical volume of saline via the same procedures. At approximately 4 weeks post-procedure, both cohorts will then undergo a post-intervention clinical assessment. Finally, both cohorts will undergo a post-intervention fMRI of their brain.

Official Title

A Randomized, Double Blind, Placebo-controlled Study of the Effects of Stellate Ganglion Block on Neural Activity and Symptoms in Participants With Post-traumatic Stress Disorder

Quick Facts

Study Start:2022-08-01
Study Completion:2025-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05391971

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-65 years of age
  2. 2. Chronic (at least one month post-trauma) DSM-5 PTSD symptoms
  3. 3. CAPS-5 Past Month score ≥ 26
  4. 4. Meets current DSM-5 PTSD diagnosis
  5. 5. Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines)
  6. 6. Willing and able to provide informed consent
  1. 1. History of stellate ganglion block treatment
  2. 2. Allergy to local anesthetics (e.g. ropivacaine, bupivacaine)
  3. 3. Allergy to iodinated contrast agents
  4. 4. Diagnosis of bipolar I disorder with a past year manic episode
  5. 5. Diagnosis of a psychotic disorder or psychotic symptoms
  6. 6. Diagnosis of current moderate or severe substance use disorder
  7. 7. History of neurological disease (that involves the brain), seizure, or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion)
  8. 8. Significant recent suicidal ideation or significant suicidal behavior in the past 12 months or suicidal ideation with imminent risk that warrants a higher level of care
  9. 9. Concurrent trauma focused psychotherapy
  10. 10. Pregnancy (to be ruled out by urine ß-HCG)
  11. 11. Metallic implants or devices contraindicating magnetic resonance imaging by interfering with patient safety or fMRI data collection; cases will be cleared by the Principal Investigator and Center for Brain Imaging
  12. 12. Morbid obesity (BMI \>4 kg/m2)
  13. 13. Current use of opioids, cocaine, or benzodiazepines (as assessed by urine toxicology)
  14. 14. Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily.
  15. 15. Cardiac conditions or any prior heart surgeries
  16. 16. Respiratory conditions such as COPD or untreated asthma
  17. 17. History of heavy metal poisoning
  18. 18. History of neck or throat surgeries
  19. 19. Vocal cord problems or paralysis
  20. 20. Untreated high blood pressure
  21. 21. Current cancer diagnosis
  22. 22. Diagnosis of Guillain-Barré syndrome
  23. 23. Diagnosis of Parkinson's Disease
  24. 24. Unable to take 7 days off of blood thinners

Contacts and Locations

Study Contact

Paul Glimcher, PhD
CONTACT
212-263-8169
Paul.Glimcher@nyulangone.org
Ryan Walters
CONTACT
ryan.walters@nyulangone.org

Principal Investigator

Paul Glimcher, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Paul Glimcher, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

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 Date2022-08-01
Study Completion Date2025-08-15

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2025-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder