A Pilot Study of SPG Block for PTSD

NCT ID: NCT05743543

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2023-06-01

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Active SPG block

The block will be performed using a topical aerosolized nasal spray followed by the administration of a local anesthetic.

Group Type: EXPERIMENTAL

Sphenopalatine ganglion block

Intervention Type: OTHER

The block is performed with a nasoscope and the administration of a local anesthetic.

Interventions

Sphenopalatine ganglion block

The block is performed with a nasoscope and the administration of a local anesthetic.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Diana Martinez

Clinical professor in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NYSPI

New York, New York, United States

Countries

United States

Other Identifiers

8104

Identifier Type: -

Identifier Source: org_study_id