A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder

NCT01629537 | Completed Phase 2 DMC

• 1 other identifier: NMCSD.2010.0157
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

Keywords

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PSTD Scale (CAPS)

  The CAPS is generally considered the gold standard for PTSD assessment, and will be used to determine severity of PTSD symptoms compared to the 1 week pre baseline measures at enrollment

  1 week

Secondary Outcomes (6)

• PTSD Checklist Military Version (PCL-M)

  1 week

• The Patient Health Questionnaire 9 (PHQ-9)

  1 week

• Beck Anxiety Inventory (BAI)

  1 week

• Sheehan Disability Scale (SDS)

  1 week

• Behavioral Reactivity Test (BRT)

  1 week

Study Arms (2)

Placebo

OTHER

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.

Procedure: Placebo Procedure

Stellate Ganglion Block (SGB)

EXPERIMENTAL

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.

Procedure: Stellate Ganglion Block injection with ropivicane

Interventions

Stellate Ganglion Block injection with ropivicane PROCEDURE

For participants receiving the stellate ganglion injection with ropivicaine, a 22 g needle will be directed percutaneously to the anterolateral C6 vertebral body Using ultrasound guidance to avoid the nearby vascular structures and identify the appropriate vertebral level and tissue plane. After negative aspiration for blood and CSF, and digital subtraction, 2cc of Iohexol,(Omnipaque 180) will be injected through the needle under live fluoroscopy to visualize dye spread over the pre-vertebral plane At this point, 7 cc 0.5% ropivicaine will be injected and the needle will be removed.

Stellate Ganglion Block (SGB)

Placebo Procedure PROCEDURE

In participants randomized to the placebo injection, the same positioning, monitoring, sterile preparation and technique and local anesthesia protocol will be used. The 22 g needle will instead be placed in the subcutaneous, superficial tissues overlying the C6 tubercle, but superficial enough that the prevertebral fascial plane of the stellate ganglion will not be breached. Using fluoroscopic guidance, this needle will be injected with 2 cc of contrast dye to confirm superficial spread. The needle will then be injected with 5 cc of preservative free normal saline and the needle will be removed.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

United States Naval Medical Center San Diego

San Diego, California, 92134-1005, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Steven Hanling, MD, CDR

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychaitry Research Director, Mental Health Directorate

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 27, 2012
• Study Start: June 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)