Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy (PRECONISE)

January 11, 2022 updated by: Maillard Louis, Central Hospital, Nancy, France

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects.
Time Frame: 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
Baseline (up to 2 weeks after a diagnosis of epilepsy for a duration of 1h30)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of impaired cognitive functions according to the cognitive domain assessed
Time Frame: 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
Baseline, 6 months, 12 months, 3 years, 6 years and 10 years after the baseline (for a duration of 1h30 at each assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Louis Maillard, Pr, Professor of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2021

Primary Completion (Anticipated)

February 17, 2022

Study Completion (Anticipated)

February 1, 2026

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • n°2020-A00404-35

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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