Attentional Impairment in People With Epilepsy

Epilepsy Clinical Trial

— ETAPE  

Official title:

Attentional Impairment in People With Epilepsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04379128
• Other study ID #: 2019-A02748-49
• Status: Not yet recruiting
• Start date: May 2020
• Est. completion date: August 2025

Study information

• Verified date: April 2020
• Source: Central Hospital, Nancy, France
• Contact: helene BRISSART, Dr
• Phone: 383851689
• Email: h.brissart[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 272
• Est. completion date: August 2025
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Attentional tasks
a neuropsychological assessment of attentional task, executive task and interview is proposed to patients or normal control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	digit span	immediate memory task	5 minutes
Other	verbal fluency	executive task	5 minutes
Other	incompatibility TAP subtest	executive task	8 minutes
Other	flexibility TAP subtest	executive task	8 minutes
Other	Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)	Depression scale score 0 to 24	3 minutes
Other	GENERALIZED ANXIETY DISORDER (GAD-7)	ANXIETY scale score : 0 to 21	3 minutes
Primary	d2-r	selective attention task	10 minutes
Secondary	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
Secondary	alertness attention TAP Subtest	a cross appears on the screen. press the key when the cross appears	8 minutes
Secondary	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