Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy

Epilepsy Clinical Trial

— PRECONISE  

Official title:

Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04727931
• Other study ID #: n°2020-A00404-35
• Status: Recruiting
• Start date: February 17, 2021
• Est. completion date: February 1, 2026

Study information

• Verified date: January 2022
• Source: Central Hospital, Nancy, France
• Contact: Natacha Forthoffer
• Phone: 03.83.85.20.77
• Email: n.forthoffer[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 1, 2026
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Cognition
• Cognition Disorders
• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
France	Department of neurology - Hospital of Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects.	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	Baseline (up to 2 weeks after a diagnosis of epilepsy for a duration of 1h30)
Secondary	Proportion of impaired cognitive functions according to the cognitive domain assessed	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	Baseline, 6 months, 12 months, 3 years, 6 years and 10 years after the baseline (for a duration of 1h30 at each assessment)