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NCT01629537 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
A Phase 2 study, sponsored by United States Naval Medical Center, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT01629537 is a Phase 2 study that has completed, run by United States Naval Medical Center, San Diego. The registered enrollment target is 41 participants.
The verdict
NCT01629537, a Phase 2 study, has completed, sponsored by United States Naval Medical Center, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study 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
Interventions
- PROCEDURE Stellate Ganglion Block injection with ropivicane
- PROCEDURE Placebo Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01629537
The ClinicalTrials.gov registry entry for NCT01629537 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Naval Medical Center, San Diego, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Stellate Ganglion Block injection with ropivicane is the first listed.
NCT01629537 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01629537 about?
NCT01629537 is a clinical study titled "A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder". 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 societ...
What is the current status of trial NCT01629537?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2011-06. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01629537?
The interventions under investigation include: Stellate Ganglion Block injection with ropivicane (PROCEDURE), Placebo Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT01629537?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
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