Back to resultsA Pilot Study of SPG Block for PTSD
Primary Purpose
Post Traumatic Stress Disorder
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Sphenopalatine ganglion block
Sponsored by
About this trial
This is an interventional other trial for Post Traumatic Stress Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active SPG block
Arm Description
The block will be performed using a topical aerosolized nasal spray followed by the administration of a local anesthetic.
Outcomes
Primary Outcome Measures
feasibility: number of participants completing the 8-week study
feasibility: number of participants completing the 8-week study
tolerability: number of adverse events
tolerability: number of adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT05743543
First Posted
January 31, 2023
Last Updated
June 30, 2023
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT05743543
Brief Title
A Pilot Study of SPG Block for PTSD
Official Title
A Feasibility Study of a Sphenopalatine Ganglion (SPG) Block for Post Traumatic Stress Disorder (PTSD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 28, 2025 (Anticipated)
Primary Completion Date
March 30, 2030 (Anticipated)
Study Completion Date
March 30, 2035 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active SPG block
Arm Type
Experimental
Arm Description
The block will be performed using a topical aerosolized nasal spray followed by the administration of a local anesthetic.
Intervention Type
Other
Intervention Name(s)
Sphenopalatine ganglion block
Intervention Description
The block is performed with a nasoscope and the administration of a local anesthetic.
Primary Outcome Measure Information:
Title
feasibility: number of participants completing the 8-week study
Description
feasibility: number of participants completing the 8-week study
Time Frame
8 weeks
Title
tolerability: number of adverse events
Description
tolerability: number of adverse events
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of SPG Block for PTSD
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