Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-05-18
Brief Title:
Neurologic Deficits and Recovery in Chronic Subdural Hematoma
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Neurologic Deficits and Recovery in Chronic Subdural Hematoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Chronic subdural hematoma cSDH is one of the most common problems treated by neurosurgeons particularly as the population ages While often dismissed as a benign problem it has become clear that cSDH is associated with worse long term functional and cognitive outcomes compared to matched controls Though surgical techniques for treatment of cSDH are becoming more effective and safe a persisting problem of fluctuating stroke-like neurological deficits has re-emerged Such deficits are not always directly related to hematoma mass effect and not always relieved with surgical decompression but can result in prolonged hospital course additional workup and sometimes even additional invasive treatments While the cause of such events is unknown we recently documented for the first time that massive waves of spreading depolarization can occur in these patients and were closely linked to such neurologic deficits in some patients In the current study we plan to expand on these preliminary findings with rigorous standardized application of post operative subdural electrocorticography monitoring pioneered at our institution to detect SD We also plan to build on our large retrospective analysis estimating the overall incidence of such deficits in cSDH patients by assessing multiple proposed risk factors for SD In addition for the first time we will assess the short- and long-term consequences of cSDH and SD with detailed functional cognitive and headache related outcome measurement These assessments are based on several remarkable cases we have observed with time-locked neurologic deterioration associated with recurrent SD This study qualifies as a mechanistic clinical trial in that we will be prospectively assigning patients to the intervention of SD monitoring and assessing outcomes related to the occurrence of SD This constitutes the application of a novel measure of brain signaling and assessing biomarkers of these physiologic processes of SD These studies will provide critically needed information on this novel mechanism for neurologic deficits and worse outcomes after cSDH evacuation Upon successful completion we would identify a targetable mechanism for poor outcomes that occur commonly in patients with cSDH This overall strategy offers the opportunity to radically improve the care of patients with cSDH by focusing on clinical trials of pharmacologic therapies for neurologic deficits in patients with cSDH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None