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

Primary Purpose

Post Traumatic Stress Disorder (PTSD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stellate Ganglion Block injection with ropivicane
Placebo Procedure
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder (PTSD) focused on measuring Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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

Sites / Locations

  • United States Naval Medical Center San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Placebo

Stellate Ganglion Block (SGB)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PTSD Checklist Military Version (PCL-M)
The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. It is used to screen and diagnose individuals for PTSD, as well as monitoring symptom change during and after treatment. To be compared to the 1 week pre baseline measures at enrollment
The Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. To be compared to the 1 week pre baseline measures at enrollment
Beck Anxiety Inventory (BAI)
A 21-question multiple-choice self-report inventory that is used for measuring the severity of an individual's anxiety. To be compared to the 1 week pre baseline measures at enrollment
Sheehan Disability Scale (SDS)
Assesses disability in work/school activities, family relationships, and social functioning, and it evaluates the functional impact of psychiatric disorders. To be compared to the 1 week pre baseline measures at enrollment
Behavioral Reactivity Test (BRT)
To be compared to the 1 week pre baseline measures at enrollment
Automated Neuropsychological Assessment Metric (ANAM)
Computer-based assessments of cognitive domains including attention, concentration, reaction time, memory, processing speed, and decision-making. Evaluate changes in an individual's cognitive status over time. To be compared to the 1 week pre baseline measures at enrollment.

Full Information

First Posted
June 22, 2012
Last Updated
March 28, 2017
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01629537
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder (PTSD)
Keywords
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Other
Arm Description
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.
Arm Title
Stellate Ganglion Block (SGB)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stellate Ganglion Block injection with ropivicane
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician Administered PSTD Scale (CAPS)
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
PTSD Checklist Military Version (PCL-M)
Description
The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. It is used to screen and diagnose individuals for PTSD, as well as monitoring symptom change during and after treatment. To be compared to the 1 week pre baseline measures at enrollment
Time Frame
1 week
Title
The Patient Health Questionnaire 9 (PHQ-9)
Description
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. To be compared to the 1 week pre baseline measures at enrollment
Time Frame
1 week
Title
Beck Anxiety Inventory (BAI)
Description
A 21-question multiple-choice self-report inventory that is used for measuring the severity of an individual's anxiety. To be compared to the 1 week pre baseline measures at enrollment
Time Frame
1 week
Title
Sheehan Disability Scale (SDS)
Description
Assesses disability in work/school activities, family relationships, and social functioning, and it evaluates the functional impact of psychiatric disorders. To be compared to the 1 week pre baseline measures at enrollment
Time Frame
1 week
Title
Behavioral Reactivity Test (BRT)
Description
To be compared to the 1 week pre baseline measures at enrollment
Time Frame
1 week
Title
Automated Neuropsychological Assessment Metric (ANAM)
Description
Computer-based assessments of cognitive domains including attention, concentration, reaction time, memory, processing speed, and decision-making. Evaluate changes in an individual's cognitive status over time. To be compared to the 1 week pre baseline measures at enrollment.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Hanling, MD, CDR
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
United States Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134-1005
Country
United States

12. IPD Sharing Statement

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

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