Attentional Impairment in People With Epilepsy (ETAPE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Other: Attentional tasks

• Study Type: Observational
• Enrollment (Anticipated): 272

Contacts and Locations

• Study Contact: Name: helene BRISSART, Dr; Phone Number: +33 383851689; Email: h.brissart@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

people with epilepsy versus normal control

Description

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...)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with epilepsy; Attentional tasks : D2-R task and TAP battery (sustained attention, alertness, divided attention) executive task : digit span, incompatibility and flexibility task (TAP battery), verbal fluencies depression score (NDDI-E scale) and anxiety score (GAD-7 scale)	Other: Attentional tasks; a neuropsychological assessment of attentional task, executive task and interview is proposed to patients or normal control
Normal controls; Attentional tasks : D2-R task and TAP battery (sustained attention, alertness, divided attention) executive task : digit span, incompatibility and flexibility task (TAP battery), verbal fluencies depression score (NDDI-E scale) and anxiety score (GAD-7 scale)	Other: Attentional tasks; a neuropsychological assessment of attentional task, executive task and interview is proposed to patients or normal control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
d2-r	selective attention task	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sustained attention TAP Subtest	Your task is to press the key as quickly as possible whenever two successive patterns have the same shape	15 minutes
alertness attention TAP Subtest	a cross appears on the screen. press the key when the cross appears	8 minutes
divided attention TAP Subtest	first task :a cross appears on the screen in which a varying number of crosses appear simultaneously. when four of these crosses form a square, then please press the key as quickly as possible. second task: in this task you will hear a high and a low tone in sequence. you must decide whether the same tone occurs twice in a row. Please press the key as quickly as possible.	5 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
digit span	immediate memory task	5 minutes
verbal fluency	executive task	5 minutes
incompatibility TAP subtest	executive task	8 minutes
flexibility TAP subtest	executive task	8 minutes
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)	Depression scale score 0 to 24	3 minutes
GENERALIZED ANXIETY DISORDER (GAD-7)	ANXIETY scale score : 0 to 21	3 minutes

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 2019-A02748-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No