Clinical trial NCT01629537: A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
Official title: A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder (PTSD)
Keywords: Post Traumatic Stress Disorder
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2012-06-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Post Traumatic Stress Disorder (PTSD), is a devastating condition which causes distress or impairment in social, occupational or other important aspects of functioning. The occurrence of PTSD in the military is on the rise. This has significantly impacted military members, their families, and society as a whole. According to an expert panel convened by the Institute of Medicine in 2007, the effectiveness of most currently employed PTSD therapies is low. Safe and effective treatments are urgently needed. The specific aim of this investigation is to evaluate the effectiveness of a novel approach to relieve PTSD symptoms, utilizing a procedure commonly used in pain management, a Stellate Ganglion Block (SGB) with local anesthesia. Male soldiers experiencing moderate to severe symptoms of PTSD will be recruited for evaluation of Stellate Ganglion Block with local anesthesia as an intervention for PTSD treatment. Participants will be randomized to receive either the SGB with local anesthesia to C6 tubercle or a sham procedure involving a subcutaneous saline injection to the neck. The PTSD symptoms before and after the procedure will be measured using a comprehensive clinician-administered scale, self-report measures, objective measures of cognitive ability, and physiologic reactivity measures. Subjects will undergo assessment prior to the procedure, one week following the procedure, one month and 3 months following the procedure. Patients receiving sham injections will be allowed to cross over to the treatment group. Based on published case reports of Lipov et al in Chicago and Mulvaney et al from Walter Reed Medical Center, who utilized this technique to successfully treat soldiers with combat-related PTSD, we predict that the use of Stellate Ganglion Block will result in reduction of PTSD symptoms as measured by clinician-administered scales, self-report measures, objective measures of cognitive ability, and physiologic reactivity measures, leading to a significant and lasting reduction of PTSD symptoms.


Eligibility criteria: 1. Gender: Male and Female
2. Minimum Age/ Maximum Age: Over the age of 18
3. 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

Primary outcomes:
measure: Clinician Administered PSTD Scale (CAPS)
timeFrame: 1 week
Secondary outcomes:
measure: PTSD Checklist Military Version (PCL-M)
timeFrame: 1 week
measure: The Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 1 week
measure: Beck Anxiety Inventory (BAI)
timeFrame: 1 week
measure: Sheehan Disability Scale (SDS)
timeFrame: 1 week
measure: Behavioral Reactivity Test (BRT)
timeFrame: 1 week
measure: Automated Neuropsychological Assessment Metric (ANAM)
timeFrame: 1 week
Other outcomes:
Locations:
city: San Diego
country: United States
facility: United States Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Steven Hanling, MD, CDR
role: PRINCIPAL_INVESTIGATOR
References: