Neurologic Deficits and Recovery in Chronic Subdural Hematoma

Study Overview
=================
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.

Official Title
-----------------
Neurologic Deficits and Recovery in Chronic Subdural Hematoma

Conditions
-----------------
Chronic Subdural Hematoma

Intervention / Treatment
-----------------
* Diagnostic Test: ECoG monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm study performing subdural ECoG monitoring to assess for presence or absence of spreading depolarization.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECoG monitoring<br>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<br>* Brief (1-5 days) of post operative ECoG monitoring to detect spreading depolarization.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGOS | Extended Glasgow outcome scale 1(dead)- 8(upper good recovery) | 30day, 90 day, 180 day | 
| MoCA | Montreal Cognitive Assessment (1-30) 30 is the best | 30day, 90 day, 180 day | 
| NIH toolbox cognitive battery | The NIH Toolbox Cognitive Battery provides an overall summary score along with fluid and crystallized cognition summary scores. | 30day, 90 day, 180 day | 
| PROMIS 29 profile | 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 | 30day, 90 day, 180 day | 
| TBI QOL | 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 | 30day, 90 day, 180 day | 
| Headache disability Index | 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. | 30day, 90 day, 180 day |