Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy
- Conditions
- CognitionEpilepsy
- Interventions
- Behavioral: Neuropsychological assessement and questionnaires
- Registration Number
- NCT04727931
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Newly diagnosed epileptic patients Neuropsychological assessement and questionnaires 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. Normal controls Neuropsychological assessement and questionnaires 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.
- Primary Outcome Measures
Name Time Method The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects. Baseline (up to 2 weeks after a diagnosis of epilepsy for a duration of 1h30) Neuropsychological assessment:
* BVMT-R
* RL/RI-16
* Digit span forward and backward (WASI-IV)
* Stroop test
* Verbal fluency
* TMT
* Code
* Oral naming
Questionnaires:
* NDDI-E
* GAD-7
* Beck inventory
* STAI
* CRI-q
- Secondary Outcome Measures
Name Time Method Proportion of impaired cognitive functions according to the cognitive domain assessed Baseline, 6 months, 12 months, 3 years, 6 years and 10 years after the baseline (for a duration of 1h30 at each assessment) Participants are assessed 6 times
Neuropsychological assessment:
* BVMT-R
* RL/RI-16
* Digit span forward and backward (WASI-IV)
* Stroop test
* Verbal fluency
* TMT
* Code
* Oral naming
Questionnaires:
* NDDI-E
* GAD-7
* Beck inventory
* STAI
* CRI-q
Trial Locations
- Locations (1)
Department of neurology - Hospital of Nancy
🇫🇷Nancy, France