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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02888925
Other study ID # 2013-A00515-40
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 2013
Est. completion date March 2020

Study information

Verified date July 2019
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date March 2020
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
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

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

Locations

Country Name City State
France Service de Neurologie, Hôpital Central, CHU de Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals day 0
Secondary 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) day 0 and after 12 to 18 months
Secondary 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) day 0 and after 24 to 30 months