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NCT Number: NCT05391971

Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years of age
  • Chronic (at least one month post-trauma) DSM-5 PTSD symptoms
  • CAPS-5 Past Month score ≥ 26
  • Meets current DSM-5 PTSD diagnosis
  • Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines)
  • Willing and able to provide informed consent

Exclusion criteria

  • History of stellate ganglion block treatment
  • Allergy to local anesthetics (e.g. ropivacaine, bupivacaine)
  • Allergy to iodinated contrast agents
  • Diagnosis of bipolar I disorder with a past year manic episode
  • Diagnosis of a psychotic disorder or psychotic symptoms
  • Diagnosis of current moderate or severe substance use disorder
  • 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)
  • 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
  • Concurrent trauma focused psychotherapy
  • Pregnancy (to be ruled out by urine ß-HCG)
  • 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
  • Morbid obesity (BMI >4 kg/m2)
  • Current use of opioids, cocaine, or benzodiazepines (as assessed by urine toxicology)
  • Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily.
  • Cardiac conditions or any prior heart surgeries
  • Respiratory conditions such as COPD or untreated asthma
  • History of heavy metal poisoning
  • History of neck or throat surgeries
  • Vocal cord problems or paralysis
  • Untreated high blood pressure
  • Current cancer diagnosis
  • Diagnosis of Guillain-Barré syndrome
  • Diagnosis of Parkinson's Disease
  • Unable to take 7 days off of blood thinners

Treatment and study plan

Bupivacaine

Drug

At the C6 level, a total of 7cc of 0.5% bupivacaine will be injected slowly at this level, with negative aspiration every 2cc. The same procedure will be repeated at the C4 level directed towards the upper cervical ganglion ventral to the longus colli muscle with a total of 3cc of 0.5% bupivacaine.

Other names: Marcaine

Saline

Drug

At the C6 level, a total of 7cc of saline control will be injected slowly at this level, with negative aspiration every 2cc. The same procedure will be repeated at the C4 level directed towards the upper cervical ganglion ventral to the longus colli muscle with a total of 3cc of saline control.

Primary outcomes

  1. Change in Skin Conductance Response (SCR) Amount

    Time frame: Week 2, Week 8

    SCR will be reported as the number of sweat glads that are activated. The more emotionally aroused an individual is, the more the SCR amount is increased. SCR will be measured during three related viewing, learning, and choice tasks, quantified as the changes between the pre-intervention fMRI scan (visit 2) and the post-intervention fMRI scan (visit 5).

  2. Change in Cerebral Blood Flow Levels

    Time frame: Week 2, Week 8

    Blood flow levels will be obtained from Blood Oxygen Level Dependent (BOLD) fMRI signals during three related viewing, learning, and choice tasks, quantified as the changes between the pre-intervention fMRI scan (visit 2) and the post-intervention fMRI scan (visit 5).

Secondary outcomes

  1. Posttraumatic Stress Disorder Checklist (PCL-5) Score

    Time frame: Week 1

    The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.

  2. Posttraumatic Stress Disorder Checklist (PCL-5) Score

    Time frame: Week 7

    The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.

  3. Posttraumatic Stress Disorder Checklist (PCL-5) Score

    Time frame: Week 15

    The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.

  4. Patient Health Questionnaire-9 (PHQ-9) Score

    Time frame: Week 1

    PHQ-9 consists of 9 items. Participants report how often they have been bothered by each item over the last 2 weeks with a score 0 (not at all) to 3 (nearly every day). The total score range is 0-27; the higher the score, the more severe the depression.

  5. Patient Health Questionnaire-9 (PHQ-9) Score

    Time frame: Week 7

    PHQ-9 consists of 9 items. Participants report how often they have been bothered by each item over the last 2 weeks with a score 0 (not at all) to 3 (nearly every day). The total score range is 0-27; the higher the score, the more severe the depression.

  6. Patient Health Questionnaire-9 (PHQ-9) Score

    Time frame: Week 15

    PHQ-9 consists of 9 items. Participants report how often they have been bothered by each item over the last 2 weeks with a score 0 (not at all) to 3 (nearly every day). The total score range is 0-27; the higher the score, the more severe the depression.

  7. State-Trait Anxiety Inventory (STAI) - Form Y1 Score

    Time frame: Week 1

    STAI - Form Y1 is a commonly used measure of trait and state anxiety that consists of 20 statement which people have used to describe themselves. Each statement is scored from 1 (Not at all) to 4 (very much so). The total score range is 20-80; STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

  8. State-Trait Anxiety Inventory (STAI) - Form Y1 Score

    Time frame: Week 7

    STAI - Form Y1 is a commonly used measure of trait and state anxiety that consists of 20 statement which people have used to describe themselves. Each statement is scored from 1 (Not at all) to 4 (very much so). The total score range is 20-80; STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

  9. State-Trait Anxiety Inventory (STAI) - Form Y1 Score

    Time frame: Week 15

    STAI - Form Y1 is a commonly used measure of trait and state anxiety that consists of 20 statement which people have used to describe themselves. Each statement is scored from 1 (Not at all) to 4 (very much so). The total score range is 20-80; STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

  10. Intolerance of Uncertainty Scale - Short Form (IUS-12) Score

    Time frame: Week 1

    IUS-12 is a 12-item self-report questionnaire where items are rated on 5-point Likert scales. IUS-12 is based on a definition of general uncertainty-related reactions that may be present in different anxiety disorders. Each item is scored from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). The total score range is 12-60; the higher the score, the greater the intolerance of uncertainty.

  11. Intolerance of Uncertainty Scale - Short Form (IUS-12) Score

    Time frame: Week 7

    IUS-12 is a 12-item self-report questionnaire where items are rated on 5-point Likert scales. IUS-12 is based on a definition of general uncertainty-related reactions that may be present in different anxiety disorders. Each item is scored from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). The total score range is 12-60; the higher the score, the greater the intolerance of uncertainty.

  12. Intolerance of Uncertainty Scale - Short Form (IUS-12) Score

    Time frame: Week 15

    IUS-12 is a 12-item self-report questionnaire where items are rated on 5-point Likert scales. IUS-12 is based on a definition of general uncertainty-related reactions that may be present in different anxiety disorders. Each item is scored from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). The total score range is 12-60; the higher the score, the greater the intolerance of uncertainty.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 26, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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