Clinical trial NCT04379128: Attentional Impairment in People With Epilepsy
Official title: Attentional Impairment in People With Epilepsy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epilepsy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with epilepsy versus normal control

Brief summary: Epilepsy is one of the most common chronic neurological conditions.It leads to cognitive impairment in 20-50% of patients with a structural form.

In comparison with seizures, these cognitive disorders are a major additional factor in occupational, social and family disability. They are particularly frequent (50%) in temporal epilepsies and preferably concern memory and language skills.

The cognitive consequences of epilepsy are therefore well described in the following areas: episodic memory, language, executive functions.

Concerning attentional abilities, a recent review has highlighted the lack of work in this specific field in order to properly measure the prevalence and nature of attentional disorders in epileptic patients. Indeed, attentional abilities are often mentioned in studies, but attention is a complex domain defined by four modalities: alertness, selective attention, divided attention and sustained attention. No study systematically assesses all of these modalities.

The objective of this study is to evaluate the prevalence and nature of attentional disorders in epileptic patients compared to control subjects.


Eligibility criteria: Patients:

Inclusion Criteria:

* Patient with epilepsy, according to Fisher et al. (2005).
* Patient with written informed consent
* affiliation to a social security regime is compulsory
* Individuals who have received full information about the organization of the research and have not objected to their participation and the use of their data.
* Patient 18 years of age and older

Normal controls:

Individuals who have received full information about the organization of the research and have not objected to their participation and the use of their data.

* People 18 years of age and older
* People with no neurological and/or psychiatric history

Exclusion Criteria:

for patients: with another progressive neurological condition for all People of full age who are subject to a legal protection measure or who are unable to express their consent People deprived of their liberty by a judicial or administrative decision People who regularly use psychoactive substances (cannabis, alcohol...)

Primary outcomes:
measure: d2-r
timeFrame: 10 minutes
Secondary outcomes:
measure: sustained attention TAP Subtest
timeFrame: 15 minutes
measure: alertness attention TAP Subtest
timeFrame: 8 minutes
measure: divided attention TAP Subtest
timeFrame: 5 minutes
Other outcomes:
measure: digit span
timeFrame: 5 minutes
measure: verbal fluency
timeFrame: 5 minutes
measure: incompatibility TAP subtest
timeFrame: 8 minutes
measure: flexibility TAP subtest
timeFrame: 8 minutes
measure: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
timeFrame: 3 minutes
measure: GENERALIZED ANXIETY DISORDER (GAD-7)
timeFrame: 3 minutes
Locations:
Study officials:
References:
citation: Brissart H, Forthoffer N, Maillard L. Attention disorders in adults with epilepsy. Determinants and therapeutic strategies. Rev Neurol (Paris). 2019 Mar;175(3):135-140. doi: 10.1016/j.neurol.2019.01.394. Epub 2019 Feb 28.