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NCT05743543 Clinical Trial

A Pilot Study of SPG Block for PTSD

Post Traumatic Stress Disorder Clinical Trial

Official title:
A Feasibility Study of a Sphenopalatine Ganglion (SPG) Block for Post Traumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05743543
Other study ID # 8104
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date May 28, 2019
Est. completion date June 1, 2023

Study information
Verified date February 2024
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Some patients with Post Traumatic Stress Disorder (PTSD) respond only partially to medication. This study is a pilot study investigating whether blocking the SPG helps reduce the symptoms of PTSD. This study does not involve treatment with medications. It is a proof of principal study.

Description:

The sphenopalatine ganglion (SPG) is a collection of neurons involved in autonomic regulation (which refers to bodily processes that are automatic like heart rate and blood pressure). Blocking the SPG is used to treat disorders, such as migraines or cluster headaches (short, severe headaches that occur together). The procedure will be performed by a doctor who specializes in ear, nose throat surgery. The block consists of the injection of a numbing agent (similar to the type used by dentists) to the SPG. After the SPG block, we will follow patients for 8 weeks to see how they feel.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Participants with a principal diagnosis of PTSD on stable dose of psychiatric medication or in stable psychotherapy for at least 3 months, who experience residual symptoms. - Participants who understand all study procedures and can undergo informed consent Exclusion Criteria: - Participants with a medical disorder, for whom study participation could be deleterious (neurologic, cardiac, renal or infectious disease) - Pregnant or breast feeding participants - Participants who are on an anticoagulant, such as warfarin, or otherwise have a medical condition that increases bleeding risk

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sphenopalatine ganglion block
The block is performed with a nasoscope and the administration of a local anesthetic.

Locations
Country Name City State
United States NYSPI New York New York

Sponsors (1)
Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary feasibility: number of participants completing the 8-week study feasibility: number of participants completing the 8-week study 8 weeks
Primary tolerability: number of adverse events tolerability: number of adverse events 8 weeks
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