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Search / Trial NCT05427500

Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder

Launched by THE ROYAL'S INSTITUTE OF MENTAL HEALTH RESEARCH · Jun 17, 2022

Trial Information

Current as of May 19, 2025

Unknown status

Keywords

Stellate Gangllion Block Canadian Armed Forces Veterans Royal Canadian Mounted Police

ClinConnect Summary

Posttraumatic Stress Disorder (PTSD) is a trauma- and stress-related disorder arising from an experienced or witnessed traumatic event, most commonly actual or threatened death, serious injury, or sexual violence. There is a distinct pattern of intrusion and avoidance, as well as negative alterations in cognitions, mood, arousal, and reactivity, leading to serious impairments in personal, social and occupational functioning (1). The risk of PTSD is elevated in military and public safety personnel, and first responders. Despite advances in evidence-based treatments for PTSD, optimal outcomes...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Diagnosis of PTSD according to DSM-5 criteria with prominent and persistent cluster E hyperarousal symptoms
  • 2. Age 18-69 years
  • 3. Under care of a mental health clinician
  • 4. Not benefited from adequate trials of pharmacological or psychological evidence-based treatment and/or a preference and consent for a trial of SGB
  • Exclusion Criteria:
  • 1. Assessed with high risk for suicide in the last 30 days (per patient's treating clinician at OSI clinic)
  • 2. Diagnosis of bipolar or psychotic disorder
  • 3. Moderate to severe substance use within the last 30 days (based on chart and verbal report from patient)
  • 4. In process of disability assessment or legal action
  • 5. Moderate or severe TBI (based on chart and verbal report from patient)
  • 6. Pregnancy or breastfeeding
  • 7. Current anticoagulant use (eligible if can be held before the procedure)
  • 8. History of bleeding disorder (based on chart and verbal report from patient)
  • 9. Infection, mass or anatomic abnormalities at target injection site
  • 10. Myocardial infarction within 6 months of procedure (based on chart and verbal report from patient)
  • 11. Pathologic bradycardia or irregularities of heart rate or rhythm (based on chart and verbal report from patient)
  • 12. Symptomatic hypotension (BP\<90/60 + clinical symptoms of hypotension)
  • 13. Phrenic or laryngeal nerve palsy (based on chart and verbal report from patient)
  • 14. History of glaucoma (based on chart and verbal report from patient)
  • 15. Uncontrolled seizure disorder (based on chart and verbal report from patient)
  • 16. Known history of allergy to local anesthetics (based on chart and verbal report from patient)
  • 17. Severe COPD (based on chart and verbal report from patient)
  • 18. Pneumothorax (based on chart and verbal report from patient)
  • 19. Contralateral pneumonectomy or non-functional lung (based on chart and verbal report from patient)
  • 20. Active systemic infection (based on chart and verbal report from patient)
  • 21. Patient refusal/inability to tolerate procedure/positioning
  • 22. Contraindication to MR imaging
  • 23. Any other condition that in the opinion of the investigator could create a hazard to the participant's safety, endanger the study procedures, or interfere with the interpretation of study results.

About The Royal's Institute Of Mental Health Research

The Royal's Institute of Mental Health Research is a leading clinical trial sponsor dedicated to advancing the understanding and treatment of mental health disorders. Affiliated with The Royal Ottawa Mental Health Centre, the Institute conducts innovative research that bridges clinical practice and scientific inquiry. With a focus on patient-centered approaches, it aims to translate findings into effective interventions, fostering partnerships with academic institutions, healthcare providers, and community organizations. The Institute is committed to promoting mental health through rigorous research, ethical standards, and a collaborative environment that prioritizes the well-being of individuals affected by mental illness.

Locations

Patients applied

0 patients applied

Trial Officials

Rebecca Gomez, MD

Principal Investigator

Psychiatrist at the OSI Clinic at the Royal Ottawa Mental Health Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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