← Back to all trials
Not Yet Recruiting
NCT07577739
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Conditions: Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia, Cerebral Vasospasm, Autonomic Nervous System Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: University of Texas Southwestern Medical Center
Location: UT Southwestern Medical Center - Clements University Hospital NSICU Dallas Texas
Summary
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
Inclusion Criteria (Component 1 - All Enrolled Participants):
* 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)
* Brain4Care extensometry sensor placeable at an appropriate cranial site not occluded by surgical dressings or EVD hardware
* Open EVD with active continuous ICP monitoring (required for EVD clamping sub-protocol only; not required for Aims 2 or 3)
Exclusion Criteria (Component 1):
* Age younger than 18 years
* Prisoner status
* Primary NSICU admission diagnosis other than aSAH
* Active declination by subject or legally authorized representative
* Brain4Care sensor not placeable at any accessible cranial site
* Active clinical deterioration making research monitoring impractical at time of approach
* Physician-of-record declining research enrollment for clinical reasons
* Inability to provide informed consent in English
* Known pregnancy at time of enrollment
Additional Inclusion Criteria for Component 2 (Aim 3 - CSB and taVNS):
* At least one successful EVD clamping session completed
* PI documentation of Component 2 operational readiness, co-signed by qualified co-investigator or Department Director
* INR 1.5 or less and platelet count 50,000/uL or greater within 24 hours prior to each CSB procedure
* No active infection or cellulitis at right anterolateral neck
* No known allergy to ropivacaine or amide local anesthetics
* No contralateral phrenic nerve palsy or severe pre-existing respiratory compromise
* No cardiac pacemaker or implanted cardiac device contraindicating taVNS
* No allergy to electrode adhesive materials
* Continuous cardiac telemetry active and interpretable
* Resting HR 60 bpm or greater on two readings within 24 hours prior to session
* No current use of Class I or III antiarrhythmic medications
* No clinically significant AV conduction abnormality
Additional Exclusion Criteria for Component 2:
* Prior ipsilateral right-sided cervical surgery, radiation, or known anatomical distortion precluding safe C6 approach
* Hemodynamic instability with active vasopressor escalation at time of planned CSB
* Active uncontrolled tachyarrhythmia or bradyarrhythmia at time of taVNS session
* Physician-of-record declining autonomic modulation procedures for any clinical reason
* Known or suspected pregnancy
Source: ClinicalTrials.gov (NCT07577739). StuddyBuddy aggregates publicly available trial information.