Clinical trial NCT04727931: Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy
Official title: Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Cognition
Keywords: Newly diagnosed epilepsy
Cognition
Epilepsy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited in the neurology department of the hospital of Nancy. Nomal controls are recruited by display in hospital of Nancy.

Brief summary: A prospective prevalence study recorded that up to 50% of adult patients with newly diagnosed epilepsy had at least one cognitive impairment before initiation of antiepileptic drug (AED). Multiple factors exist and interact in the same patient. Cognitive impairments may affect psychiatric (loss of self-esteem, anxiety, depression) and social status (e.g., vocational aptitude, educational). These factors in turn influence cognitive abilities in a triangular and bidirectional relationship. In addition, the type of epilepsy, development in childhood or cerebral ageing, antiepileptic treatments (AED, surgery) and etiology also have an impact on cognitive performances. The burden of these factors differs from patient to another and must be determined individually. Longitudinal follow-up seems to be crucial because it will allow us to highlight the change in the cognitive profile of newly diagnosed patients over time.

The main objective is to compare the prevalence of cognitive impairment in patients with newly diagnosed epilepsy prior to the initiation of AED with healthy subjects matched on age, sex, manual laterality and socio-educational level. But also to compare the longitudinal evolution of the cognitive profile of patients with healthy controls (0 to 10 years) to determine, among the age of onset seizures, their etiology, the syndrome, the sex, the socio-educational level and the cognitive reserve, which one are related to the severity of cognitive disorders.


Eligibility criteria: Inclusion Criteria (patients):

* Individuals who have received full information about the organization of the research and have not refused to participate and to use their data.
* Person aged 16 and over
* For minor patients: the non-opposition of the parental authority holders
* Newly diagnosed epileptic patient who had never taken antiepileptic drugs.

Inclusion Criteria (normal controls):

* Individuals who have received full information about the organization of the research and have not refused to participate and to use their data.
* For minor participants: the non-opposition of the parental authority holders
* Person aged 16 and over.

Exclusion Criteria (patients):

* Person of full age who are subject to a legal protection measure or who are unable to express their consent
* Person with a progressive brain injury
* Person who regularly use psychoactive substances (cannabis, alcohol, etc.)
* Patients who started an antiepileptic treatment before the neuropsychological assessment.

Exclusion Criteria (normal controls):

* Persons of full age who are subject to a legal protection measure or who are unable to express their consent
* Person with a neurological (traumatic brain injury, stroke, etc.) and/or psychiatric (mental illness, depression, etc.) history.
* People who regularly use psychoactive substances (cannabis, alcohol, etc.).

Primary outcomes:
measure: The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects.
timeFrame: Baseline (up to 2 weeks after a diagnosis of epilepsy for a duration of 1h30)
Secondary outcomes:
measure: Proportion of impaired cognitive functions according to the cognitive domain assessed
timeFrame: Baseline, 6 months, 12 months, 3 years, 6 years and 10 years after the baseline (for a duration of 1h30 at each assessment)
Other outcomes:
Locations:
city: Nancy
country: France
facility: Department of neurology - Hospital of Nancy
Study officials:
affiliation: Professor of neurology
name: Louis Maillard, Pr
role: PRINCIPAL_INVESTIGATOR
References: