Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage (NCT07577739) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
United States300 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bland-Altman agreement between Brain4Care-derived noninvasive pressure reactivity index (nPRx) and invasive ICP-derived PRx during EVD clamping (Aim 1a)
Timeframe: During each standardized 15-minute EVD clamping session, up to one session per 24-hour period over ICU Days 1-14
2
Bland-Altman agreement between Brain4Care-derived noninvasive optimal cerebral perfusion pressure (nCPPopt) and invasive ICP-derived CPPopt during EVD clamping (Aim 1b)
Timeframe: During each standardized 15-minute EVD clamping session, up to one session per 24-hour period over ICU Days 1-14
3
Invasive ICP-derived optimal cerebral perfusion pressure (CPPopt) trajectory through the DCI window in aSAH (Aim 2a)
Timeframe: ICU admission through Day 14 post-rupture
4
NIRS-derived cerebral oximetry index (COx) trajectory through the DCI window in aSAH (Aim 2b)
Timeframe: ICU admission through Day 14 post-rupture
5
Change in invasive ICP-derived optimal cerebral perfusion pressure (CPPopt) before versus after cervical sympathetic block and taVNS (Aim 3a)
Timeframe: 60 minutes before through 60 minutes after each intervention session
6
Trial details
NCT IDNCT07577739
SponsorUniversity of Texas Southwestern Medical Center