NCT04379128

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 7, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

April 27, 2020

Last Update Submit

May 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • d2-r

    selective attention task

    10 minutes

Secondary Outcomes (3)

  • sustained attention TAP Subtest

    15 minutes

  • alertness attention TAP Subtest

    8 minutes

  • divided attention TAP Subtest

    5 minutes

Other Outcomes (6)

  • digit span

    5 minutes

  • verbal fluency

    5 minutes

  • incompatibility TAP subtest

    8 minutes

  • +3 more other outcomes

Study Arms (2)

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

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

Interventions

a neuropsychological assessment of attentional task, executive task and interview is proposed to patients or normal control

Normal controlspatients with epilepsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people with epilepsy versus normal control

You may qualify if:

  • 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

You may not qualify if:

  • 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...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

helene BRISSART, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 7, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2020

Study Completion

August 1, 2025

Last Updated

May 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share