Recruiting

Observational Study

Sponsor:

Université de Sherbrooke

Code:

NCT04759196

Conditions

Chronic Subdural Hematoma

Epilepsy; Seizure

Cortical Depression; Cortical Depolarization

Nonepileptic, Stereotypical and Intermittent Symptoms

NESIS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Topamax

Levetiracetam

Study Details

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).

Conditions

Chronic Subdural Hematoma

Epilepsy; Seizure

Cortical Depression; Cortical Depolarization

Nonepileptic, Stereotypical and Intermittent Symptoms

NESIS

Study ID

NCT04759196

Start date

Mar 1, 2021

Status verified date

Apr, 2021

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Topamax

TPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID.

Levetiracetam

LEV : 500 mg BID, with increase of 1000 mg die divided in two doses each week until efficacy, to a maximum of 1500 mg BID.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

suzie adam, MD

5146990518suzie.adam@usherbrooke.ca

Mathieu Lévesque, MD

Levesque@neurorivesud.ca

Locations

Centre Hospitalier Universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Christian Iorio-Morin, MD, PhD

christian.iorio-morin@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Apr 30, 2021

Last verified

Apr, 2021

Keywords

  • Transient neurological symptoms
  • Levetiracetam; keppra
  • Lamotrigine; lamictal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2021-04-30.