Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Université de Sherbrooke
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Between-group difference in the number of TNS reported at 6 month in participants with a positive Nonepileptic, Stereotyped, Intermittent Symptoms (NESIS) score (4 and more)
Study Overview
Brief 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).
Detailed Description
Patients presenting with transient neurological symptoms in the context of subdural hemorrhage may present a diagnostic challenge. Many of these patients end up with a probable diagnosis of epilepsy (or acute symptomatic seizures), despite a negative electroencephalogram. The investigators believe that the origin of these transient neurologic symptoms in a significant subpopulation of these patients may in fact be cortical depolarization, rather than epileptiform activity. Very specific characteristics have already been identified that differentiate these patients from those who ultimately have epilepsy. The NESIS entity (nonepileptic, stereotypical, and intermittent symptoms) has been proposed to represent this group of patients. A NESIS score was then designed to help distinguish patients with epileptiform activity (confirmed by EEG) from those likely to have cortical depolarization. In other diseases presenting cortical depolarizations, certain antiepileptic treatments (including Topiramate) have already been recognized as effective. The investigators therefore want to perform a prospective, multicenter, randomized-controlled study (Topiramate group and Levetiracetam group) to determine whether a significant difference in the response to treatment exists between Topiramate and Levetiracetam in the NESIS group compared to the non-NESIS group. In addition, in a few eligible patients, the investigators will implant an electrocorticography electrode to demonstrate the existence of cortical depolarizations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
The participant will not know the medication they are taking. When accepting to participate, they are going to have the full list of possible side effects, without knowing which one are link to which medication.
The doctors in charge of administering the questionnaires will be blind. The person in charge of analyzing the results will also be blind.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
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.
Intervention: Levetiracetam (Drug)
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.
Intervention: Topamax (Drug)
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.
Intervention: Levetiracetam (Drug)
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.
Intervention: Topamax (Drug)
Outcomes
Primary Outcomes
Between-group difference in the number of TNS reported at 6 month in participants with a positive Nonepileptic, Stereotyped, Intermittent Symptoms (NESIS) score (4 and more)
Time Frame: Through study completion, an average of 3 years
The aim of this study is to demonstrate the efficacy of Topiramate in the treatment of patients with transient neurological symptoms in the context of chronic subdural hemorrhage with a positive NESIS score (4 and more), in whom usual epilepsy treatment appears to be less effective. To do this, the effect of Topiramate (shown to be effective in cortical depressions) will be compared with that of Levetiracetam (which has not been shown to be effective in cortical depressions). This is going to be done by a questionnaire that will assess the resolution of symptoms or not, or the percentage of diminution.
Secondary Outcomes
- Between-group difference in the number of TNS reported at 6 month in all participants (all NESIS scores)(Through study completion, an average of 3 years)
- Incidence of cortical spreading depression on electrocorticography in the first postoperative week of patients with preoperative TNS.(Through study completion, an average of 3 years)