EpilepsyPRECONISENCT04727931
Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy
An observational study of Epilepsy and Cognition, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- What is being tested?
- Neuropsychological assessement and questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2021to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients are recruited in the neurology department of the hospital of Nancy. Nomal controls are recruited by display in hospital of Nancy.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of neurology - Hospital of Nancy
Nancy, 54000
Forthoffer Natacha, n.forthoffer@chru-nancy.fr
About this study
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.
- Being tested
- Neuropsychological assessement and questionnaires
- Keywords
- Newly diagnosed epilepsy, Cognition, Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessement and questionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Neuropsychological assessement and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Baseline, 6 months, 12 months, 3 years, 6 years and 10 years after the baseline (for a duration of 1h30 at each assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start17 Feb 2021
- Primary completion17 Feb 2022 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maillard Louis, Central Hospital, Nancy, France
- Investigators
- Louis Maillard, Pr, Principal investigator, Professor of neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727931
- Sponsor's protocol ID
- n°2020-A00404-35
- Acronym
- PRECONISE
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy
- ClinicalTrials.gov ID
- NCT04727931
- Acronym / sponsor ID
- PRECONISE / n°2020-A00404-35
- Keywords
- Newly diagnosed epilepsy, Cognition, Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 17 Feb 2022 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed epileptic patients | – | Behavioral: Neuropsychological assessement and questionnairesNewly 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 | – | Behavioral: Neuropsychological assessement and questionnairesMatched (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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are recruited in the neurology department of the hospital of Nancy. Nomal controls are recruited by display in hospital of Nancy.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessement and questionnairesNeuropsychological assessement including memory, working memory, executive function, oral naming and speed processing tests. There are questionnaires to assess mood disorders, anxiety and cognitive reserve. | Behavioural | Newly diagnosed epileptic patients, Normal controls |
Primary outcome
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
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Maillard, Pr principal investigator
Professor of neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Cognition, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha Forthoffer (03.83.85.20.77, n.forthoffer@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.