Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Some patients with chronic subdural hematomas and transient neurological symptoms do not respond to standard antiepileptic drugs. The investigators think that some of them could have cortical depression rather than epileptic discharges. After an intensive literature review, the investigators found out that some antiepileptic dugs (Lamotrigine, Topiramate) were found to be efficient to treat cortical depression in other conditions (migraine, subarachnoid hemorrhage). In contrast, some other drugs (Levetiracetam) were not proved to be efficient. Knowing that, the investigators want to compare the efficacy of Topiramate against Levetiracetam in two different groups, the NESIS group (based on a NESIS score of 4 or more - increased risk of cortical depression) versus a non-NESIS group (score of 3 or less - increased risk of epileptic discharges).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Université de Sherbrooke
• Treatments: Levetiracetam; Topiramate

Criteria

Inclusion Criteria:

• Be aged ≥ 18 years

• Chronic subdural hematoma

• Transient neurological symptoms (Sensory, motor, cerebellar or speech symptoms, lasting 6 hours or less)

• Initial negative EEG

Exclusion Criteria:

• Contraindications to Levetiracetam

• Psychiatric history (major depression, psychosis, risk of suicide)

• History of hypersensitivity to LEV (anaphylaxis, angioedema, skin reaction)

• Contraindications to Topiramate

• History of hypersensitivity to TPM

• Glaucoma

• Past of nephrolithiasis

• Known epilepsy or past seizure before the current subdural hemorrhage

• Actual taking of an antiepileptic drug

• Intracranial pathology not caused by subdural hematoma (intra-parenchymal hemorrhage, neoplasia)

• Pregnancy or planning to

• Inability to carry out the necessary follow-ups for the study

• Refusal of the attending physician