Chronic Subdural HematomaNCT05900557
Neurologic Deficits and Recovery in Chronic Subdural Hematoma
A study testing ECoG monitoring in people with Chronic Subdural Hematoma, run by University of New Mexico.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- ECoG monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic/ subacute subdural hematoma deemed necessary for surgical evacuation,
- Ability to consent or have LAR consent
Who cannot join
- emergent need for evacuation,
- acute traumatic subdural hematoma, and
- severe baseline disability (mRS>2) (modified Rankin Scale)
About this study
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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- ECoG monitoring
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECoG monitoringDiagnostic test
Brief (1-5 days) of post operative ECoG monitoring to detect spreading depolarization.
| Study group | Role | What they receive |
|---|---|---|
| ECoG monitoring | Experimental | 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. Receives: Diagnostic Test: ECoG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-5 days
Secondary outcomes (6)
eGOS
Extended Glasgow outcome scale 1(dead)- 8(upper good recovery)
Measured: 30day, 90 day, 180 day
MoCA
Montreal Cognitive Assessment (1-30) 30 is the best
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 30day, 90 day, 180 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Mar 2025
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Why it stopped: PI has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study performing subdural ECoG monitoring to assess for presence or absence of spreading depolarization.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900557
- Sponsor's protocol ID
- 1454683
- Status last verified
- Apr 2025
- First submitted
- 18 May 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurologic Deficits and Recovery in Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT05900557
- Acronym / sponsor ID
- 1454683
- Conditions
- Chronic Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study performing subdural ECoG monitoring to assess for presence or absence of spreading depolarization.
| Arm | Type | Receives |
|---|---|---|
| ECoG monitoring | Experimental | Diagnostic Test: ECoG monitoringPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic/ subacute subdural hematoma deemed necessary for surgical evacuation,
- Ability to consent or have LAR consent
Key exclusion criteria (3 listed)
- emergent need for evacuation,
- acute traumatic subdural hematoma, and
- severe baseline disability (mRS>2) (modified Rankin Scale)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECoG monitoringBrief (1-5 days) of post operative ECoG monitoring to detect spreading depolarization. | Diagnostic test | ECoG monitoring |
Primary outcome
Post operative neurologic deterioration.
Time frame: 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.
6 secondary outcomes
eGOS
Time frame: 30day, 90 day, 180 day
MoCA
Time frame: 30day, 90 day, 180 day
NIH toolbox cognitive battery
Time frame: 30day, 90 day, 180 day
PROMIS 29 profile
Time frame: 30day, 90 day, 180 day
TBI QOL
Time frame: 30day, 90 day, 180 day
Headache disability Index
Time frame: 30day, 90 day, 180 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ECoG monitoring in people with Chronic Subdural Hematoma, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative neurologic deterioration. (time frame: 1-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.