NCT04302181

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2021

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

March 6, 2020

Last Update Submit

September 8, 2022

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 1 month and 3 months

  • 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).

    Baseline, 1 month and 3 months

Secondary Outcomes (4)

  • Change in PHQ-9 (Patient Health Questionnaire-9)

    Baseline, 1 month and 3 months

  • Change in Brief Inventory of Psychosocial Functioning

    Baseline, 1 month and 3 months

  • Change in GAD-7 (General Anxiety Disorder Screener)

    Baseline, 1 month and 3 months

  • Change in PTCI (Posttraumatic Cognitions Inventory)

    Baseline, 1 month and 3 months

Study Arms (1)

Stellate Ganglion Block

EXPERIMENTAL

One time administration of a stellate ganglion block

Drug: Ropivacaine injection

Interventions

Ropivacaine injectionDRUG

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

Also known as: Naropin
Stellate Ganglion Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (7)

  • 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.

    PMID: 29362795BACKGROUND

  • 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.

    PMID: 27187898BACKGROUND

  • 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.

    PMID: 29276402BACKGROUND

  • 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.

    PMID: 19034755BACKGROUND

  • 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.

    PMID: 27612365BACKGROUND

  • 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.

    PMID: 25269132BACKGROUND

  • 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.

    PMID: 36050896DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Alan Peterson, PhD, ABPP

    University of Texas Health San Antonio Texas at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
Masked clinical diagnostic assessor for the CAPS-5
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A small open-label treatment study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

October 5, 2020

Primary Completion

July 1, 2021

Study Completion

December 3, 2021

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)