Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

This is a two-component prospective study of adult aneurysmal subarachnoid hemorrhage (aSAH) patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. Component 1 (active upon IRB approval) validates Brain4Care (B4C) extensometry-derived noninvasive cerebral autoregulation (CA) indices against invasive ICP-derived equivalents in aSAH patients with open external ventricular drains (EVDs), and characterizes the prospective natural history of multi-modal CA parameter evolution through the delayed cerebral ischemia (DCI) window (admission through Day 14). Component 2 (activated upon PI readiness declaration) assesses the within-subject effect of cervical sympathetic block (CSB) and transcutaneous auricular vagal nerve stimulation (taVNS) on CA parameters in enrolled aSAH patients.

Eligibility criteria

Qualifiers

Age 18 years or older

Primary diagnosis of aneurysmal subarachnoid hemorrhage (aSAH), confirmed by imaging

Admitted to the NSICU at Clements University Hospital, UT Southwestern Medical Center

Informed consent obtained from subject or legally authorized representative (as defined under Texas Health and Safety Code Section 166.039)

Disqualifiers

Age younger than 18 years

Prisoner status

Primary NSICU admission diagnosis other than aSAH

Active declination by subject or legally authorized representative

Trial design

Treatments tested in this trial

  • Right-Sided Cervical Sympathetic Block at C6
  • Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

Treatment groups

300 Participants
are divided into 2 treatment groups