Status:
ENROLLING_BY_INVITATION
Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder
Lead Sponsor:
The Royal's Institute of Mental Health Research
Collaborating Sponsors:
Ottawa Hospital Research Institute
Conditions:
PTSD
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
The most common treatment for Posttraumatic Stress Disorder (PTSD) is trauma-focused therapy and/or prescription of medication(s). However, these treatments may not directly reduce symptoms associated...
Detailed Description
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 sex...
Eligibility Criteria
Inclusion
- Diagnosis of PTSD according to DSM-5 criteria with prominent and persistent cluster E hyperarousal symptoms
- Age 18-69 years
- Under care of a mental health clinician
- Not benefited from adequate trials of pharmacological or psychological evidence-based treatment and/or a preference and consent for a trial of SGB
Exclusion
- Assessed with high risk for suicide in the last 30 days (per patient's treating clinician at OSI clinic)
- Diagnosis of bipolar or psychotic disorder
- Moderate to severe substance use within the last 30 days (based on chart and verbal report from patient)
- In process of disability assessment or legal action
- Moderate or severe TBI (based on chart and verbal report from patient)
- Pregnancy or breastfeeding
- Current anticoagulant use (eligible if can be held before the procedure)
- History of bleeding disorder (based on chart and verbal report from patient)
- Infection, mass or anatomic abnormalities at target injection site
- Myocardial infarction within 6 months of procedure (based on chart and verbal report from patient)
- Pathologic bradycardia or irregularities of heart rate or rhythm (based on chart and verbal report from patient)
- Symptomatic hypotension (BP\<90/60 + clinical symptoms of hypotension)
- Phrenic or laryngeal nerve palsy (based on chart and verbal report from patient)
- History of glaucoma (based on chart and verbal report from patient)
- Uncontrolled seizure disorder (based on chart and verbal report from patient)
- Known history of allergy to local anesthetics (based on chart and verbal report from patient)
- Severe COPD (based on chart and verbal report from patient)
- Pneumothorax (based on chart and verbal report from patient)
- Contralateral pneumonectomy or non-functional lung (based on chart and verbal report from patient)
- Active systemic infection (based on chart and verbal report from patient)
- Patient refusal/inability to tolerate procedure/positioning
- Contraindication to MR imaging
- 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.
Key Trial Info
Start Date :
March 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05427500
Start Date
March 30 2024
End Date
January 30 2027
Last Update
July 25 2025
Active Locations (1)
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1
The Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, K1Z 7K4