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NCT05391971 · ClinicalTrials.gov registry record · Phase 4
Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder
A Phase 4 study of Post Traumatic Stress Disorder, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05391971: Recruiting Phase 4 study of Post Traumatic Stress Disorder, sponsored by NYU Langone Health.
NCT05391971 is a Phase 4 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 80 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05391971, a Phase 4 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Bupivacaine
- DRUG Saline
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 4 |
What NCT05391971 shows while recruiting
NCT05391971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine is the first listed.
NCT05391971 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05391971 about?
NCT05391971 is a clinical study titled "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 a...
What is the current status of trial NCT05391971?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2022-08-01. Estimated completion is 2026-04-01.
What conditions does trial NCT05391971 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT05391971?
The interventions under investigation include: Bupivacaine (DRUG), Saline (DRUG).
Who is sponsoring clinical trial NCT05391971?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05391971 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05391971's enrollment target sits among peer trials
80 135th of 262 higher than 121 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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