Neurologic Deficits and Recovery in Chronic Subdural Hematoma

Chronic Subdural Hematoma Clinical Trial

Official title:

Neurologic Deficits and Recovery in Chronic Subdural Hematoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05900557
• Other study ID #: 1454683
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2025
• Est. completion date: December 2029

Study information

• Verified date: April 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic
• Neurologic Manifestations

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	eGOS	Extended Glasgow outcome scale 1(dead)- 8(upper good recovery)	30day, 90 day, 180 day
Secondary	MoCA	Montreal Cognitive Assessment (1-30) 30 is the best	30day, 90 day, 180 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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