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

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ClinicalTrials.gov Identifier: NCT02888925
Recruitment Status : Active, not recruiting
First Posted : September 5, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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).


Condition or disease Intervention/treatment Phase
Anterior Temporal Epilepsy Anterior Temporal Lobectomy Face Perception 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Neuropsychological Effects of Drug-resistant Anterior Temporal Epilepsy and Anterior Temporal Lobectomy in Face Perception
Actual Study Start Date : August 2013
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
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

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



Primary Outcome Measures :
  1. Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals [ Time Frame: day 0 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888925


Locations
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France
Service de Neurologie, Hôpital Central, CHU de Nancy
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Louis Maillard Service de Neurologie, Hôpital Central, CHU de Nancy, France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02888925     History of Changes
Other Study ID Numbers: 2013-A00515-40
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases