Stress Disorders, Post-TraumaticPhase 2NCT01533610
The Efficacy of Stellate Ganglion Block as Post-traumatic Stress Disorder (PTSD) Therapy: A Pilot Study
A Phase 2 study testing Stellate ganglion block in people with Stress Disorders, Post-Traumatic, run by Southern California Institute for Research and Education at 1 site in United States.
Trial summary
RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic stress disorder (PTSD). PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era) induced or relatively… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Stellate ganglion block
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Include significant PTSD symptoms with severe hyper-arousal symptoms.
- Clinician Administered PTSD Scales (CAPS) score, with a total score ≥ 50 needed for enrollment.
- Hyper-arousal severity identified by a high score on the CAPS D scale and a ≥ 10 beat per minute increase in heart rate during the subject's verbal recollection of a standardized version of their traumatic exposure.
Who cannot join
- Include psychiatric and medical conditions that would make patients poor candidates for an outpatient procedure.
- Subjects must be able to be cooperative for the procedure and free of significant medical problems that would pose a constant threat to life.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Long Beach Healthcare system
Long Beach, California, 90803
Michael T Alkire, MD, 562-826-8000 ext. 4405, malkire@uci.edu
Michael T Alkire, MD
About this study
Official title: The Efficacy of Stellate Ganglion Block as PTSD Therapy: A Pilot Study
RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic stress disorder (PTSD).
PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era) induced or relatively recently induced PTSD (from deployment in Afghanistan or Iraq as part of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND).
Read the detailed description
Objectives:
- Stellate ganglion blocks will be performed in a small sample (n = 12) of the local patient population that suffers from PTSD in order to replicate other preliminary findings.
- The parameters that lead to a successful treatment response will be evaluated by comparing and contrasting the results obtained in younger (n=6) OEF/OIF generation veterans versus older (n=6) Vietnam generation veterans.
- The individual difference variables that might lead to successful treatment responses will be studied by obtaining correlative measures of psychological and psychometric data and responses to standardized tests.
Research Design:
This is an open label unblinded clinical pilot case series study to determine the efficacy of stellate ganglion blockade for relief of PTSD symptoms in the Long Beach VA healthcare population.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Stellate ganglion block
- Keywords
- Post-Traumatic Stress disorder, Stellate ganglion, cervical plexus, local anesthesia, anxiety
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
Also called Cervical plexus block
Local anesthesia applied to the stellate ganglion in the neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in CAPS score activity
Measured: Baseline and weeks 1, 4, 12 and 26
Secondary outcomes (4)
Depression scale
Measured: Baseline and weeks 1, 4, 12 and 26
Anxiety scale
Measured: Baseline and weeks 1, 4, 12 and 26
Quality of life scale
Measured: Baseline and weeks 1, 4, 12 and 26
Biophysical responses
Measured: Baseline and weeks 1, 4, 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael T Alkire, MD, Principal investigator, Long Beach VA Healthcare system
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533610
- Sponsor's protocol ID
- #1125
- Status last verified
- Feb 2012
- First submitted
- 12 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Stellate Ganglion Block as PTSD Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT01533610
- Acronym / sponsor ID
- #1125
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post-Traumatic Stress disorder, Stellate ganglion, cervical plexus, local anesthesia, anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 15 Feb 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.
RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic stress disorder (PTSD).
PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era) induced or relatively recently induced PTSD (from deployment in Afghanistan or Iraq as part of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND).
Detailed description
Objectives:
- Stellate ganglion blocks will be performed in a small sample (n = 12) of the local patient population that suffers from PTSD in order to replicate other preliminary findings.
- The parameters that lead to a successful treatment response will be evaluated by comparing and contrasting the results obtained in younger (n=6) OEF/OIF generation veterans versus older (n=6) Vietnam generation veterans.
- The individual difference variables that might lead to successful treatment responses will be studied by obtaining correlative measures of psychological and psychometric data and responses to standardized tests.
Research Design:
This is an open label unblinded clinical pilot case series study to determine the efficacy of stellate ganglion blockade for relief of PTSD symptoms in the Long Beach VA healthcare population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Include significant PTSD symptoms with severe hyper-arousal symptoms.
- Clinician Administered PTSD Scales (CAPS) score, with a total score ≥ 50 needed for enrollment.
- Hyper-arousal severity identified by a high score on the CAPS D scale and a ≥ 10 beat per minute increase in heart rate during the subject's verbal recollection of a standardized version of their traumatic exposure.
Key exclusion criteria (2 listed)
- Include psychiatric and medical conditions that would make patients poor candidates for an outpatient procedure.
- Subjects must be able to be cooperative for the procedure and free of significant medical problems that would pose a constant threat to life.
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 blockAlso: Cervical plexus blockLocal anesthesia applied to the stellate ganglion in the neck | Procedure or surgery | – |
Primary outcome
Difference in CAPS score activity
Time frame: Baseline and weeks 1, 4, 12 and 26
4 secondary outcomes
Depression scale
Time frame: Baseline and weeks 1, 4, 12 and 26
Anxiety scale
Time frame: Baseline and weeks 1, 4, 12 and 26
Quality of life scale
Time frame: Baseline and weeks 1, 4, 12 and 26
Biophysical responses
Time frame: Baseline and weeks 1, 4, 12 and 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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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.
Michael T Alkire, MD principal investigator
Long Beach VA Healthcare system
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 in people with Stress Disorders, Post-Traumatic, run by Southern California Institute for Research and Education 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 2 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: status not confirmed, as of the sponsor's last update on 15 Feb 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in CAPS score activity (time frame: Baseline and weeks 1, 4, 12 and 26). 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 15 Feb 2012.