Neurologic Deficits and Recovery in Chronic Subdural Hematoma
Primary Purpose
Chronic Subdural Hematoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ECoG monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Subdural Hematoma
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ECoG monitoring
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
eGOS
Extended Glasgow outcome scale 1(dead)- 8(upper good recovery)
MoCA
Montreal Cognitive Assessment (1-30) 30 is the best
NIH toolbox cognitive battery
The NIH Toolbox Cognitive Battery provides an overall summary score along with fluid and crystallized cognition summary scores.
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05900557
Brief Title
Neurologic Deficits and Recovery in Chronic Subdural Hematoma
Official Title
Neurologic Deficits and Recovery in Chronic Subdural Hematoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm study performing subdural ECoG monitoring to assess for presence or absence of spreading depolarization.
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ECoG monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ECoG monitoring
Intervention Description
Brief (1-5 days) of post operative ECoG monitoring to detect spreading depolarization.
Primary Outcome Measure Information:
Title
Post operative neurologic deterioration.
Description
Incidence of decline in Markwalder grading scale (0[normal]-4[comatose]) or Glasgow coma scale (3[no response] to 15[normal]) by one point.
Time Frame
1-5 days
Secondary Outcome Measure Information:
Title
eGOS
Description
Extended Glasgow outcome scale 1(dead)- 8(upper good recovery)
Time Frame
30day, 90 day, 180 day
Title
MoCA
Description
Montreal Cognitive Assessment (1-30) 30 is the best
Time Frame
30day, 90 day, 180 day
Title
NIH toolbox cognitive battery
Description
The NIH Toolbox Cognitive Battery provides an overall summary score along with fluid and crystallized cognition summary scores.
Time Frame
30day, 90 day, 180 day
Title
PROMIS 29 profile
Description
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
Time Frame
30day, 90 day, 180 day
Title
TBI QOL
Description
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
Time Frame
30day, 90 day, 180 day
Title
Headache disability Index
Description
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.
Time Frame
30day, 90 day, 180 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
12. IPD Sharing Statement
Plan to Share IPD
No
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Neurologic Deficits and Recovery in Chronic Subdural Hematoma
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