NCT05743543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2019

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2019

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

4 years

First QC Date

January 31, 2023

Last Update Submit

February 14, 2024

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • feasibility: number of participants completing the 8-week study

    feasibility: number of participants completing the 8-week study

    8 weeks

  • tolerability: number of adverse events

    tolerability: number of adverse events

    8 weeks

Study Arms (1)

Active SPG block

EXPERIMENTAL

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

Other: Sphenopalatine ganglion block

Interventions

Sphenopalatine ganglion blockOTHER

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

Active SPG block

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYSPI

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Autonomic Nerve BlockNerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor in Psychiatry

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 24, 2023

Study Start

May 28, 2019

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

US(1)