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NCT05900557
Neurologic Deficits and Recovery in Chronic Subdural Hematoma
NA trial testing ECoG monitoring in Chronic Subdural Hematoma. Withdrawn.
1 March 2025
Quick facts
| Lead sponsor | University of New Mexico |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Start date | 1 March 2025 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 March 2025 |
Drugs / interventions tested
- ECoG monitoring
Conditions studied
- Chronic Subdural Hematoma — all drugs for Chronic Subdural Hematoma →
Sponsor
University of New Mexico
Who can join
40 and older, any sex, with Chronic Subdural Hematoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05900557
- Europe PMC full search
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Related trials
Other recruiting trials for Chronic Subdural Hematoma
Currently open trials in the same condition.
- NCT07245264 — Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH) · Phase 2, PHASE3 · recruiting
- NCT07144423 — Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma · NA · recruiting
- NCT07324551 — Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center · recruiting
- NCT07421453 — Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma · recruiting
- NCT06772740 — Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma · NA · recruiting
Other University of New Mexico trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05900557 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of New Mexico
- Last refreshed: 1 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05900557.
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