Neurologic Deficits and Recovery in Chronic Subdural Hematoma

Not Applicable

Withdrawn

• Conditions: Chronic Subdural Hematoma
• Interventions: Diagnostic Test: ECoG monitoring

• Registration Number: NCT05900557
• Lead Sponsor: University of New Mexico

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

Not available

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-12
• Study Start: 2025-03-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECoG monitoring	ECoG monitoring	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.

Primary Outcome Measures

Name	Time	Method
Post operative neurologic deterioration.	1-5 days	Incidence of decline in Markwalder grading scale (0\[normal\]-4\[comatose\]) or Glasgow coma scale (3\[no response\] to 15\[normal\]) by one point.

Secondary Outcome Measures

Name	Time	Method
PROMIS 29 profile	30day, 90 day, 180 day	The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain
eGOS	30day, 90 day, 180 day	Extended Glasgow outcome scale 1(dead)- 8(upper good recovery)
TBI QOL	30day, 90 day, 180 day	The TBI-QOL consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life
Headache disability Index	30day, 90 day, 180 day	The Headache Disability Index (HDI) is a 27-item questionnaire.The first two questions asks the patient to identify the frequency (1 per month; more than 1 but less than 4 per month; more than 1 per week) and intensity (mild, moderate, severe) of their headache. The remaining questions evaluate quality of life issues to determine headache disability.
NIH toolbox cognitive battery	30day, 90 day, 180 day	The NIH Toolbox Cognitive Battery provides an overall summary score along with fluid and crystallized cognition summary scores.
MoCA	30day, 90 day, 180 day	Montreal Cognitive Assessment (1-30) 30 is the best