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

Who is this study for? Patients with chronic subdural hematomas
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Be aged ≥ 18 years

• Chronic subdural hematoma

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

• Initial negative EEG

Locations
Other Locations
Canada
Centre Hospitalier Universitaire de Sherbrooke
RECRUITING
Sherbrooke
Contact Information
Primary
suzie adam, MD
suzie.adam@usherbrooke.ca
5146990518
Backup
Mathieu Lévesque, MD
Levesque@neurorivesud.ca
Time Frame
Start Date: 2021-03-01
Completion Date: 2024-12
Participants
Target number of participants: 56
Treatments
Active_comparator: NESIS - Levetiracetam
Participant with a score NESIS of 4 or more (increased risk of having cortical depression).~Levetiracetam is an anti-epileptic drug known to be inefficient in other condition with cortical depression. It will be use as an active comparator.
Experimental: NESIS - Topiramate
Participant with a score NESIS of 4 or more (increased risk of having cortical depression).~Topiramate is an anti-epileptic drug known to be efficient in other condition with cortical depression. The investigators want to test his efficacy in chronic subdural hematoma with probable cortical depression.
Active_comparator: Non NESIS - Levetiracetam
Participant with a score NESIS of 3 or less (increased risk of having epileptic discharges).~Levetiracetam is an anti-epileptic drug known to be inefficient in other condition with cortical depression. It will be use as an active comparator.~Levetiracetam should be as efficient as Topiramate in a group a participant with epileptic discharges.
Experimental: Non-NESIS - Topiramate
Participant with a score NESIS of 3 or less (increased risk of having epileptic discharges).~Topiramate is an anti-epileptic drug known to be efficient in other condition with cortical depression. The investigators want to test his efficacy in chronic subdural hematoma with probable cortical depression.~Topiramate should be as efficient as Levetiracetam in a group a participant with epileptic discharges.
Sponsors
Leads: Université de Sherbrooke

This content was sourced from clinicaltrials.gov

Similar Clinical Trials