Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05391971
Other study ID # 22-00374
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 1, 2022
Est. completion date August 15, 2025

Study information

Verified date April 2024
Source NYU Langone Health
Contact Paul Glimcher, PhD
Phone 212-263-8169
Email Paul.Glimcher@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 127
Est. completion date August 15, 2025
Est. primary completion date June 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. 18-65 years of age 2. Chronic (at least one month post-trauma) DSM-5 PTSD symptoms 3. CAPS-5 Past Month score = 26 4. Meets current DSM-5 PTSD diagnosis 5. Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines) 6. Willing and able to provide informed consent Exclusion Criteria: 1. History of stellate ganglion block treatment 2. Allergy to local anesthetics (e.g. ropivacaine, bupivacaine) 3. Allergy to iodinated contrast agents 4. Diagnosis of bipolar I disorder with a past year manic episode 5. Diagnosis of a psychotic disorder or psychotic symptoms 6. Diagnosis of current moderate or severe substance use disorder 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. 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. Concurrent trauma focused psychotherapy 10. Pregnancy (to be ruled out by urine ß-HCG) 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. Morbid obesity (BMI >4 kg/m2) 13. Current use of opioids, cocaine, or benzodiazepines (as assessed by urine toxicology) 14. Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily. 15. Cardiac conditions or any prior heart surgeries 16. Respiratory conditions such as COPD or untreated asthma 17. History of heavy metal poisoning 18. History of neck or throat surgeries 19. Vocal cord problems or paralysis 20. Untreated high blood pressure 21. Current cancer diagnosis 22. Diagnosis of Guillain-Barré syndrome 23. Diagnosis of Parkinson's Disease 24. Unable to take 7 days off of blood thinners

Study Design


Intervention

Drug:
Bupivacaine
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.
Saline
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.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Skin Conductance Response (SCR) Amount 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). Week 2, Week 8
Primary Change in Cerebral Blood Flow Levels 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). Week 2, Week 8
Secondary Posttraumatic Stress Disorder Checklist (PCL-5) Score 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. Week 1
Secondary Posttraumatic Stress Disorder Checklist (PCL-5) Score 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. Week 7
Secondary Posttraumatic Stress Disorder Checklist (PCL-5) Score 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. Week 15
Secondary Patient Health Questionnaire-9 (PHQ-9) Score 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. Week 1
Secondary Patient Health Questionnaire-9 (PHQ-9) Score 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. Week 7
Secondary Patient Health Questionnaire-9 (PHQ-9) Score 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. Week 15
Secondary State-Trait Anxiety Inventory (STAI) - Form Y1 Score 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). Week 1
Secondary State-Trait Anxiety Inventory (STAI) - Form Y1 Score 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). Week 7
Secondary State-Trait Anxiety Inventory (STAI) - Form Y1 Score 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). Week 15
Secondary Intolerance of Uncertainty Scale - Short Form (IUS-12) Score 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. Week 1
Secondary Intolerance of Uncertainty Scale - Short Form (IUS-12) Score 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. Week 7
Secondary Intolerance of Uncertainty Scale - Short Form (IUS-12) Score 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. Week 15
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Recruiting NCT05934162 - Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD N/A
Recruiting NCT05934175 - Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder N/A
Completed NCT04460014 - Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT N/A
Completed NCT05877807 - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Active, not recruiting NCT05992649 - The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject N/A
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Not yet recruiting NCT05331534 - Effect of Attentional Therapy on Post-traumatic Stress Disorder N/A
Not yet recruiting NCT03649607 - Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black N/A
Not yet recruiting NCT04076215 - Biochemical and Physiological Response to Stressogenic Stimuli N/A
Not yet recruiting NCT02545192 - A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments Phase 1
Completed NCT02329418 - Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit N/A
Active, not recruiting NCT00978484 - A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder Phase 3
Completed NCT00760734 - Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03278171 - Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
Recruiting NCT05874362 - People Bereaved by Violent Death : Negative Event Biases and Temporal Perception N/A
Terminated NCT03898843 - Assisted Animal Therapy: ReAnimal N/A
Recruiting NCT04747379 - Psychological Effect of Explicit Recall After Sedation (PEERS)
Completed NCT03248167 - Cannabidiol as a Treatment for AUD Comorbid With PTSD Phase 1/Phase 2