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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 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 1,116-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05391971
The ClinicalTrials.gov registry entry for NCT05391971 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,116-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (93% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.