Post Traumatic Stress Disorder (PTSD)Phase 2NCT01629537
A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
A Phase 2 study testing Stellate Ganglion Block injection with ropivicane in people with Post Traumatic Stress Disorder (PTSD), run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Stellate Ganglion Block injection with ropivicane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Naval Medical Center San Diego
San Diego, California, 92134-1005
About this study
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)
- Being tested
- Stellate Ganglion Block injection with ropivicane, Placebo Procedure
- Keywords
- Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion Block injection with ropivicaneProcedure or surgery
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.
Placebo ProcedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Stellate Ganglion Block injection with ropivicane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (6)
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
Behavioral Reactivity Test (BRT)
To be compared to the 1 week pre baseline measures at enrollment
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Steven Hanling, United States Naval Medical Center, San Diego
- Investigators
- Steven Hanling, MD, CDR, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629537
- Sponsor's protocol ID
- NMCSD.2010.0157
- Status last verified
- Mar 2017
- First submitted
- 22 Jun 2012
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01629537
- Acronym / sponsor ID
- NMCSD.2010.0157
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Keywords
- Post Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Jun 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Other | Procedure: Placebo ProcedureSubjects 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. |
| Stellate Ganglion Block (SGB) | Experimental | Procedure: Stellate Ganglion Block injection with ropivicaneSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion Block injection with ropivicaneFor 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. | Procedure or surgery | Stellate Ganglion Block (SGB) |
| Placebo ProcedureIn 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. | Procedure or surgery | Placebo |
Primary outcome
Clinician Administered PSTD Scale (CAPS)
Time frame: 1 week
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
6 secondary outcomes
PTSD Checklist Military Version (PCL-M)
Time frame: 1 week
The Patient Health Questionnaire 9 (PHQ-9)
Time frame: 1 week
Beck Anxiety Inventory (BAI)
Time frame: 1 week
Sheehan Disability Scale (SDS)
Time frame: 1 week
Behavioral Reactivity Test (BRT)
Time frame: 1 week
Automated Neuropsychological Assessment Metric (ANAM)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Hanling, MD, CDR principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stellate Ganglion Block injection with ropivicane in people with Post Traumatic Stress Disorder (PTSD), run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PSTD Scale (CAPS) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.