A Pilot Study of SPG Block for PTSD

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05743543
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 145

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Other: Sphenopalatine ganglion block	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Feasibility Study of a Sphenopalatine Ganglion (SPG) Block for Post Traumatic Stress Disorder (PTSD)
• Anticipated Study Start Date: Feb 28, 2023
• Anticipated Primary Completion Date: Mar 30, 2030
• Anticipated Study Completion Date: Mar 30, 2035

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active SPG block The block will be performed using a topical aerosolized nasal spray followed by the administration of a local anesthetic.	Other: Sphenopalatine ganglion block; The block is performed with a nasoscope and the administration of a local anesthetic.

Outcome Measures

Primary Outcome Measures

1. feasibility: number of participants completing the 8-week study [8 weeks]

   feasibility: number of participants completing the 8-week study

2. tolerability: number of adverse events [8 weeks]

   tolerability: number of adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diana Martinez, Clinical professor in Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT05743543
• Other Study ID Numbers: 8104
• First Posted: Feb 24, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Feb 1, 2023

• 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
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Feb 24, 2023