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 range18 Years – 65 Years
SexALL
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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