Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder (NCT05391971) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder
United States79 participantsStarted 2022-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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