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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
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Subdural Hematoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 18, 2023
    Last Updated
    June 9, 2023
    Sponsor
    University of New Mexico
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    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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