NCT04727931

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

February 17, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

January 21, 2021

Last Update Submit

January 11, 2022

Conditions

EpilepsyCognition

Keywords

Newly diagnosed epilepsyCognitionEpilepsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Study Arms (2)

Newly diagnosed epileptic patients

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.

Behavioral: Neuropsychological assessement and questionnaires

Normal controls

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.

Behavioral: Neuropsychological assessement and questionnaires

Interventions

Neuropsychological assessement and questionnairesBEHAVIORAL

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.

Newly diagnosed epileptic patientsNormal controls

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neurology - Hospital of Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Louis Maillard, Pr

    Professor of neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natacha Forthoffer

CONTACT

03.83.85.20.77n.forthoffer@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 27, 2021

Study Start

February 17, 2021

Primary Completion

February 17, 2022

Study Completion

February 1, 2026

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

FR(1)