NCT06797752

Brief Summary

Surges in the sympathetic nervous system occur at the ictus of a variety of neurological critical illnesses including intracranial hemorrhage and ischemic stroke. It is hypothesized that these exaggerated increases in sympathetic nervous activity produce maladaptations that promote secondary brain injury. One of these possible mechanisms include diffuse vasospasm that cause cerebral ischemia. Hence, methods to abrogate the sympathetic nervous system in this context are under active investigation. One possible method is the regional anesthesia technique of the stellate ganglion nerve block, which is ordinarily used for complex regional pain syndrome, but has been shown to reduce cerebral sympathetic activity and reduces vasospasm in patients with subarachnoid hemorrhage. However, its effect on the microcirculation is not clear. Hence, we propose to study patients receiving the stellate ganglion nerve block as part of their standard medical care and to image their retinal microcirculation before and after the procedure using Optical Coherence Tomography Angiography (OCTA).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress79%
Oct 2024Oct 2026

Study Start

First participant enrolled

October 7, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

December 21, 2024

Last Update Submit

November 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vascular and Perfusion Density

    Quantitative measure of retinal microperfusion

    One day

Study Arms (1)

Intervention Group

Patients receiving the stellate ganglion block

Device: OCTA Scan

Interventions

OCTA ScanDEVICE

Optical Coherence Tomography Angiography before and after receiving the stellate ganglion nerve block.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving the stellate ganglion block

You may qualify if:

  • Age 18 years or older
  • Patients receiving the stellate ganglion nerve block for an approved indication, e.g. complex regional pain syndrome

You may not qualify if:

  • Pregnancy
  • Non-English speaking
  • Temporary or permanent physical limitation that renders the patient unable to sit up and look inside OCTA device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (1)

  • Patton N, Aslam T, Macgillivray T, Pattie A, Deary IJ, Dhillon B. Retinal vascular image analysis as a potential screening tool for cerebrovascular disease: a rationale based on homology between cerebral and retinal microvasculatures. J Anat. 2005 Apr;206(4):319-48. doi: 10.1111/j.1469-7580.2005.00395.x.

    PMID: 15817102BACKGROUND

MeSH Terms

Conditions

Brain InjuriesSubarachnoid HemorrhageCerebral Hemorrhage

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Noah Jouett, DO, PhD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 21, 2024

First Posted

January 28, 2025

Study Start

October 7, 2024

Primary Completion (Estimated)

October 7, 2026

Study Completion (Estimated)

October 7, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Pilot study

Locations