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Stress Disorders, Post-TraumaticEarly Phase 1NCT04302181

Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD

A Early Phase 1 study testing Ropivacaine injection in people with Stress Disorders, Post-Traumatic, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
Ropivacaine injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
5 Oct 2020to 3 Dec 2021
Phase
Early Phase 1
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Active duty or retired military service member (age 18- 65 years)
  • PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
  • Able to speak and read English (due to standardization of outcome measures)
  • Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for the stellate ganglion block.

Who cannot join

  • Classification as high risk for suicide
  • Current serious mental health diagnosis (e.g., bipolar or psychosis)
  • Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days
  • Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding
  • Current anticoagulant use
  • History of bleeding disorder
Show all 14Show fewer
  • Infection or mass at injection site
  • Myocardial infarction within 6 months of procedure
  • Pathologic bradycardia or irregularities of heart rate or rhythm;
  • Symptomatic hypotension
  • Phrenic or laryngeal nerve palsy
  • History of glaucoma
  • Uncontrolled seizure disorder
  • History of allergy to local anesthetics

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat Posttraumatic Stress Disorder (PTSD) in Active Duty or Retired Service Members: A Pilot Study

This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Each of the 12 participants will receive ten 90-minute sessions of Massed Prolonged Exposure and an injection of a stellate ganglion block between the first and second PE sessions.

Read the detailed description

Massed PE will be conducted by doctoral-level therapists. Participants will meet with their providers for individual, 90-minute sessions. They will then be asked to complete out-of-session treatment assignments throughout the rest of the day. Between the individual therapy session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment per day, Monday through Friday, for two weeks. The stellate ganglion block injection will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block. A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration.

During PE treatment, participants will complete interim assessments of their PTSD symptoms, mood symptoms, trauma-related cognitions, and suicidal ideation proceeding sessions 6 and 10.

Being tested
Ropivacaine injection
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.

  • Ropivacaine injectionDrug

    Also called Naropin

    6.5cc of Ropivacaine HCl 0.5%, one time into the stellate ganglion

Study groups in NCT04302181
Study groupRoleWhat they receive
Stellate Ganglion BlockExperimentalOne time administration of a stellate ganglion block
Receives: Drug: Ropivacaine injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in CAPS-5 (Clinician-Administered PTSD Scale)

    A 30-item structured interview used to assess symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning.

    Measured: Baseline, 1 month and 3 months

  2. Change in PCL-5 (Posttraumatic Stress Disorder Checklist)

    A 20-item self-report measure that assesses the presence and severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5).

    Measured: Baseline, 1 month and 3 months

Secondary outcomes (4)

  1. Change in PHQ-9 (Patient Health Questionnaire-9)

    A 9-item self-report measure that assesses the presence and severity of depressive symptoms.

    Measured: Baseline, 1 month and 3 months

  2. Change in Brief Inventory of Psychosocial Functioning

    A 7-item self-report measure assessing respondents' level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living.

    Measured: Baseline, 1 month and 3 months

  3. Change in GAD-7 (General Anxiety Disorder Screener)

    A 9-item self-report measure that assesses the presence and severity of general anxiety symptoms.

    Measured: Baseline, 1 month and 3 months

  4. Change in PTCI (Posttraumatic Cognitions Inventory)

    A 36-item self-report measure that assesses self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure.

    Measured: Baseline, 1 month and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2020
  2. Study start5 Oct 2020
  3. Primary completion1 Jul 2021
  4. Study completion3 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A small open-label treatment study
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04302181
Sponsor's protocol ID
HSC20190878H
Status last verified
Sep 2022
First submitted
6 Mar 2020
Last updated
9 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.

    PubMed 29362795

  • Hanling SR, Hickey A, Lesnik I, Hackworth RJ, Stedje-Larsen E, Drastal CA, McLay RN. Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):494-500. doi: 10.1097/AAP.0000000000000402.

    PubMed 27187898

  • Gunduz OH, Kenis-Coskun O. Ganglion blocks as a treatment of pain: current perspectives. J Pain Res. 2017 Dec 14;10:2815-2826. doi: 10.2147/JPR.S134775. eCollection 2017.

    PubMed 29276402

  • Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available.

    PubMed 19034755

  • Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518.

    PubMed 27612365

  • Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151.

    PubMed 25269132

  • Peterson AL, Straud CL, Young-McCaughan S, McCallin JP, Hoch M, Roux NP 3rd, Koch L, Lara-Ruiz J, Roache JD, Hein JM, Blount TH; STRONG STAR Consortium. Combining a stellate ganglion block with prolonged exposure therapy for posttraumatic stress disorder: A nonrandomized clinical trial. J Trauma Stress. 2022 Dec;35(6):1801-1809. doi: 10.1002/jts.22873. Epub 2022 Sep 1.

    PubMed 36050896

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ropivacaine injection in people with Stress Disorders, Post-Traumatic, run by The University of Texas Health Science Center at San Antonio at 2 sites 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 4 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 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Change in CAPS-5 (Clinician-Administered PTSD Scale) (time frame: Baseline, 1 month and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04302181, which also lists 7 linked publications.

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 9 Sep 2022.

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