A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
Post Traumatic Stress Disorder (PTSD)
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder (PTSD) focused on measuring Post Traumatic Stress Disorder
Eligibility Criteria
- Gender: Male and Female
- Minimum Age/ Maximum Age: Over the age of 18
- Accepts Healthy Volunteers:
Yes, but must be experiencing mild to severe symptoms of PTSD
Inclusion Criteria will include subjects who:
- Subjects, (male and/or female), experiencing moderate-to-severe PTSD Symptoms
- Subjects, (male and/or female), who elect to undergo the SGB procedure.
- DEERS Eligible
Exclusion Criteria will include subjects who:
- Have an acute, unstable medical condition i.e., temperature, blood pressure, heart rate outside normal limits; electrolyte abnormalities; mental conditions which preclude informed consent/unable to make decisions independently; on antibiotic therapy; uncontrolled seizures; nausea/vomiting; night sweats; blood dyscrasias.
- Have acute infections or cardiac compromise or irregularities of heart rate or rhythm.
- Pathologic bradycardia
- Have local infections of the anterior neck region
- Have severe pulmonary disease, (in severe pulmonary disease, the patient may experience severe shortness of breath on minimal exertion [even at rest], require supplemental oxygen, is progressively disabled and may have a constant cough and associated wheeze).
- Are anticoagulated
- Have a blood clotting disorder
- Have an American Society of Anesthesiologists (ASA) physical status score of 3 or higher (severe systemic disease, not incapacitating)
- Have allergic reactions to local anesthetics and / or contrast dyes,
- Have conditions or disorders that affect cognitive functioning, including stroke, past or present diagnosis of psychosis,
- Have conditions that invalidate testing procedures (e.g., English not first language, inability to write, speak, read, etc.)
- Have Horner's syndrome on the right side
- Have a diagnosis of glaucoma
- Are pregnant
Sites / Locations
- United States Naval Medical Center San Diego
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Placebo
Stellate Ganglion Block (SGB)
Subjects 1 month post in the placebo group who demonstrate either the same level of PTSD severity at enrollment or worsening of the condition (i.e., CAPS score greater than or equal to 40) will be offered SGB treatment and crossed over to active treatment. Patients who cross over from placebo to active SGB treatment will be followed one week, one month and three months after cross over.
Subjects assigned to SGB arm will undergo SGB procedure and be followed one week, one month and three months after procedure or until CAPS score is below 40.