Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy (PRECONISE)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Epilepsy; Cognition

Treatments: Behavioral: Neuropsychological assessement and questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT04727931

n°2020-A00404-35

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.).

Trial design

300 participants in 2 patient groups

Newly diagnosed epileptic patients

Description:

Newly diagnosed epileptic patients who have never be treated by antiepileptic drugs and who have no psychiatric (mental illness) and/or evolutive neurological history and for minor patients the non-opposition of the parental authority holders.

Treatment:

Behavioral: Neuropsychological assessement and questionnaires

Normal controls

Description:

Matched (on age, gender, socio-educationnal level and manual laterality) healthy controls who have no psychiatric (depression, mental illness) and/or neurological (stroke, traumatic brain injury, etc.) history and for minor patients the non-opposition of the parental authority holders.

Treatment:

Behavioral: Neuropsychological assessement and questionnaires