Trials / Unknown
UnknownNCT04727931
Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Central Hospital, Nancy, France · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Neuropsychological assessement and questionnaires | Neuropsychological assessement including memory, working memory, executive function, oral naming and speed processing tests. There are questionnaires to assess mood disorders, anxiety and cognitive reserve. |
Timeline
- Start date
- 2021-02-17
- Primary completion
- 2022-02-17
- Completion
- 2026-02-01
- First posted
- 2021-01-27
- Last updated
- 2022-01-26
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04727931. Inclusion in this directory is not an endorsement.