Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443177
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-06
Brief Title:
The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to see that in addition to existing therapy how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture
Detailed Description:
The Investigators overarching hypothesis is that sympathetic innervation plays a substantial role in conferring cerebral vasospasm CVS risk to aneurysmal subarachnoid hemorrhage aSAH patients and is associated with severity of clinical features and outcomes Specifically the Investigators surmise that central hypothalamic and local arterial adventitia sympathetic inputs are upregulated following SAH and integrate at the level of the neuromuscular junction to abnormally increase cerebrovascular tone The long-term goal of this program is to use orthogonal approaches to undertake a comprehensive electrophysiological functional genomics and advanced imaging analysis of CVS The Investigators hope is these data inform therapeutic pathways to modulate implicated pathogenic mechanisms and reduce CVS incidence and severity thereby improving overall clinical outcomes in aSAH In the short-term the Investigators will focus on elucidating the modulatory role of cervical spinal cord stimulator SCS on sympathetic innervation to the cerebral vasculature
This is a Phase 2 prospective randomized single center study assessing the safety and efficacy of SCS for reducing vasospasm aSAH patients who meet inclusion criteria and provide informed consent will be randomly assigned to SCS or a sham procedure Subjects will be blinded until the end of the study with no allowance for crossover Temporary leads will stimulate utilizing a paradigm established from prior human studies and the effect measured with daily transcranial doppler TCD Leveraging prior experience in vascular and functional neurosurgery the Investigators group is poised to make a substantial impact Below the Investigators outline a feasible framework to modulate sympathetic drivers of CVS
Aim 1 Perform feasibility analysis of SCS placement and operation in the aSAH setting It is presently unknown how temporary SCS will impact the workflow and care of patients with acutely ruptured cerebral aneurysms Given the rate of new aSAH cases at the Investigators center 50 per year initiation of prospective data collection and longitudinal study are required The Investigators will comprehensively assess operative time for electrode implantation lead function and data transmission efficiency in the ICU site infectionpressure injury and untoward systemic effects hypotension arrhythmia for all patients enrolled at the Investigators center
Aim 2 Quantify the sympathetic modulating effect of SCS on cerebral blood flow during CVS Further characterization of the sympathetic contribution to CVS will establish a rationale for functionalneuromodulatory therapies such as SCS The Investigators will perform cervical epidural stimulation through temporary leads and monitor effects on cerebral blood flow by daily TCD Experiments will continue throughout the 14-day CVS window to capture longitudinal changes in sympathetic tone and vascular response Quantitative TCD metrics velocity resistance Lindegaard ratio will be compared between on- and off-stimulation epochs The Investigators study will not only fundamentally advance the Investigators understanding of vasospasm but also provide a framework to elucidate mechanisms of other cerebrovascular conditions
This is a Phase 2 prospective randomized single center study assessing the safety and efficacy of SCS for reducing vasospasm aSAH patients who meet inclusion criteria and provide informed consent will be randomly assigned to SCS or a sham procedure Subjects will be blinded until the end of the study with no allowance for crossover Temporary leads will stimulate utilizing a paradigm established from prior human studies and the effect measured with daily transcranial doppler TCD Leveraging prior experience in vascular and functional neurosurgery the Investigators group is poised to make a substantial impact Below the Investigators outline a feasible framework to modulate sympathetic drivers of CVS
Aim 1 Perform feasibility analysis of SCS placement and operation in the aSAH setting It is presently unknown how temporary SCS will impact the workflow and care of patients with acutely ruptured cerebral aneurysms Given the rate of new aSAH cases at the Investigators center 50 per year initiation of prospective data collection and longitudinal study are required The Investigators will comprehensively assess operative time for electrode implantation lead function and data transmission efficiency in the ICU site infectionpressure injury and untoward systemic effects hypotension arrhythmia for all patients enrolled at the Investigators center
Aim 2 Quantify the sympathetic modulating effect of SCS on cerebral blood flow during CVS Further characterization of the sympathetic contribution to CVS will establish a rationale for functionalneuromodulatory therapies such as SCS The Investigators will perform cervical epidural stimulation through temporary leads and monitor effects on cerebral blood flow by daily TCD Experiments will continue throughout the 14-day CVS window to capture longitudinal changes in sympathetic tone and vascular response Quantitative TCD metrics velocity resistance Lindegaard ratio will be compared between on- and off-stimulation epochs The Investigators study will not only fundamentally advance the Investigators understanding of vasospasm but also provide a framework to elucidate mechanisms of other cerebrovascular conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB | OTHER | UAB | None |