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

Primary Purpose

Anterior Temporal Epilepsy, Anterior Temporal Lobectomy, Face Perception

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mooney test
Benton Face Recognition test
Face inversion effect test
Face composite effect test
Cambridge Face Memory Test
Matching different view test
Memorizing and recognition of new faces test
Memorizing and recognition of new objects test
Recognition of celebrities and access to semantic information test
Lobectomy
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anterior Temporal Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Service de Neurologie, Hôpital Central, CHU de Nancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Epilepsy

Control

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals

Secondary Outcome Measures

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)
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)

Full Information

First Posted
August 31, 2016
Last Updated
July 23, 2019
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02888925
Brief Title
Anterior Temporal Epilepsy Neuropsychological Assessment of Faces
Acronym
ATENA-F
Official Title
Evaluation of Neuropsychological Effects of Drug-resistant Anterior Temporal Epilepsy and Anterior Temporal Lobectomy in Face Perception
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Temporal Epilepsy, Anterior Temporal Lobectomy, Face Perception

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epilepsy
Arm Type
Other
Arm Description
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
Arm Title
Control
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Mooney test
Intervention Type
Other
Intervention Name(s)
Benton Face Recognition test
Intervention Type
Other
Intervention Name(s)
Face inversion effect test
Intervention Type
Other
Intervention Name(s)
Face composite effect test
Intervention Type
Other
Intervention Name(s)
Cambridge Face Memory Test
Intervention Type
Other
Intervention Name(s)
Matching different view test
Intervention Type
Other
Intervention Name(s)
Memorizing and recognition of new faces test
Intervention Type
Other
Intervention Name(s)
Memorizing and recognition of new objects test
Intervention Type
Other
Intervention Name(s)
Recognition of celebrities and access to semantic information test
Intervention Type
Procedure
Intervention Name(s)
Lobectomy
Intervention Description
In patients with anterior temporal epilepsy, at 6 to 12 months after inclusion, depending on surgery decision taken after pre-surgery conventional intercritical assessment
Primary Outcome Measure Information:
Title
Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals
Time Frame
day 0
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Maillard
Organizational Affiliation
Service de Neurologie, Hôpital Central, CHU de Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie, Hôpital Central, CHU de Nancy
City
Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Anterior Temporal Epilepsy Neuropsychological Assessment of Faces

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