Anterior Temporal Epilepsy Neuropsychological Assessment of Faces (ATENA-F)

July 23, 2019 updated by: Central Hospital, Nancy, France

Evaluation of Neuropsychological Effects of Drug-resistant Anterior Temporal Epilepsy and Anterior Temporal Lobectomy in Face Perception

The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face perception by comparison of performances of epileptic patients and control individuals, sex-, age- and socio-educational level-matched.

Secondary purposes are to prospectively evaluate neuropsychological impact of anterior temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face perception (exploratory study).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • Service de Neurologie, Hôpital Central, CHU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

ALL:

  • Informed consent
  • Affiliation to social security
  • Preliminary medical examination

PATIENTS WITH EPILEPSY:

  • Symptomatic drug-resistant anterior temporal epilepsy (confirmed with video-electroencephalography and magnetic resonance imaging and if necessary intracerebral SEEG exploration)
  • Patient needing anterior temporal lobectomy and undergoing pre-surgery conventional intercritical assessment for surgery decision
  • Nonverbal IQ ≥ 70 (WAIS-IV)
  • At least 6 successful VOSP tests (perception test)

Exclusion Criteria:

ALL:

  • persons under legal protection or incapable to consent
  • Persons deprived of liberty by juridical or administrative decision

PATIENTS WITH EPILEPSY:

- Sever visual disorders of neurological or ophthalmological origin

CONTROL INDIVIDUALS:

  • Psychiatric or neurological disorders
  • Important ophthalmological disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Epilepsy
Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy
Other: Mooney test
Other: Benton Face Recognition test
Other: Face inversion effect test
Other: Face composite effect test
Other: Cambridge Face Memory Test
Other: Matching different view test
Other: Memorizing and recognition of new faces test
Other: Memorizing and recognition of new objects test
Other: Recognition of celebrities and access to semantic information test
Procedure: Lobectomy
In patients with anterior temporal epilepsy, at 6 to 12 months after inclusion, depending on surgery decision taken after pre-surgery conventional intercritical assessment
Other: Control
Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)
Other: Mooney test
Other: Benton Face Recognition test
Other: Face inversion effect test
Other: Face composite effect test
Other: Cambridge Face Memory Test
Other: Matching different view test
Other: Memorizing and recognition of new faces test
Other: Memorizing and recognition of new objects test
Other: Recognition of celebrities and access to semantic information test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals
Time Frame: day 0
day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)
Time Frame: day 0 and after 12 to 18 months
day 0 and after 12 to 18 months
Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)
Time Frame: day 0 and after 24 to 30 months
day 0 and after 24 to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Louis Maillard, Service de Neurologie, Hôpital Central, CHU de Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00515-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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