Neurologic Deficits and Recovery in Chronic Subdural Hematoma

NCT05900557 | Withdrawn

• 1 other identifier: 1454683
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• Post operative neurologic deterioration.

  Incidence of decline in Markwalder grading scale (0\[normal\]-4\[comatose\]) or Glasgow coma scale (3\[no response\] to 15\[normal\]) by one point.

  1-5 days

Secondary Outcomes (6)

• eGOS

  30day, 90 day, 180 day

• MoCA

  30day, 90 day, 180 day

• NIH toolbox cognitive battery

  30day, 90 day, 180 day

• PROMIS 29 profile

  30day, 90 day, 180 day

• TBI QOL

  30day, 90 day, 180 day

Study Arms (1)

ECoG monitoring

EXPERIMENTAL

Patients undergoing standard of care surgical evacuation of cSDH. will have subdural ECoG monitoring electrode placed crossing frontal and temporal lobes for 1-5 days of post operative monitoring. All subjects will undergo long term followup testing.

Diagnostic Test: ECoG monitoring

Interventions

ECoG monitoring DIAGNOSTIC_TEST

Brief (1-5 days) of post operative ECoG monitoring to detect spreading depolarization.

ECoG monitoring

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic/ subacute subdural hematoma deemed necessary for surgical evacuation,
• Ability to consent or have LAR consent

You may not qualify if:

• emergent need for evacuation,
• acute traumatic subdural hematoma, and
• severe baseline disability (mRS\>2) (modified Rankin Scale)

Sponsors & Collaborators

• University of New Mexico: lead

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm study performing subdural ECoG monitoring to assess for presence or absence of spreading depolarization.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 12, 2023
• Study Start: March 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share