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Completed

NCT Number: NCT05743543

A Pilot Study of SPG Block for PTSD

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NYSPI

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sphenopalatine ganglion block

Other

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

Primary outcomes

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

    Time frame: 8 weeks

    feasibility: number of participants completing the 8-week study

  2. tolerability: number of adverse events

    Time frame: 8 weeks

    tolerability: number of adverse events

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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