Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD)

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic Subdural Hematoma (cSDH) is an extremely common problem, particularly in the aging population, where fluid like collections compress the brain, frequently requiring surgical drainage. After drainage, 25-50% of patients experience post operative neurologic deficits such as weakness or confusion that are often not explained by problems such as seizure, stroke, or mass effect from the fluid and blood. Recent subdural recordings have demonstrated that some of these neurological deficits may be related to waves of spreading depolarization (SD), which cause temporary neurological dysfunction. Our overall objective is to examine the relationship between neurological deficits and SD and to assess feasibility of a pilot trial to determine if a strategy of NMDA-R antagonism can effectively reduce SD and improve clinical recovery.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of New Mexico
• Treatments: Memantine

Criteria

Inclusion Criteria:

• Surgical intervention for chronic or subacute SDH

• Electrode strip placed at time of surgery (for clinical indication of enhanced seizure monitoring)

• Age 18-100

• SD detected within 48h of surgery

Exclusion Criteria:

• Acute SDH requiring large craniotomy (some acute subacute component within cSDH is acceptable)

• Strip not feasible or safe to place at conclusion of surgery

• Known or suspected infection

• Recurrent surgery

• Subjects who previously participated in the study (contralateral or recurrent hematoma)

• Severe renal impairment (CrCl 5-29)

• Use of other NMDA antagonist

• Severe hepatic impairment

• Child-Pugh Class C hepatic impairment

• Known allergy to memantine

• Memantine use at time of admission

• Inability to obtain enteral feeding (oral or via NGT)

• Patients on acetylcholinesterase inhibitors

• Women of child-bearing age who are unwilling to undergo dual contraception for 30 days.