Anterior Temporal EpilepsyATENA-FNCT02888925
Anterior Temporal Epilepsy Neuropsychological Assessment of Faces
A study testing Mooney test, Benton Face Recognition test and Face inversion effect test in people with Anterior Temporal Epilepsy and Anterior Temporal Lobectomy, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Temporal Epilepsy, Anterior Temporal Lobectomy, Face Perception
- What is being tested?
- Mooney test, Benton Face Recognition test and Face inversion effect test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Being tested
- Mooney test, Benton Face Recognition test, Face inversion effect test, Face composite effect test, Cambridge Face Memory Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mooney testOther
Benton Face Recognition testOther
Face inversion effect testOther
Face composite effect testOther
Cambridge Face Memory TestOther
Matching different view testOther
Memorizing and recognition of new faces testOther
Memorizing and recognition of new objects testOther
Recognition of celebrities and access to semantic information testOther
LobectomyProcedure or surgery
In patients with anterior temporal epilepsy, at 6 to 12 months after inclusion, depending on surgery decision taken after pre-surgery conventional intercritical assessment
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Other | 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 Receives: 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 |
| Control | Other | 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) Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals
Measured: day 0
Secondary outcomes (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)
Measured: 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)
Measured: day 0 and after 24 to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startAug 2013
- Primary completionSep 2017
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Temporal EpilepsyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Maillard, Principal investigator, Service de Neurologie, Hôpital Central, CHU de Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888925
- Sponsor's protocol ID
- 2013-A00515-40
- Acronym
- ATENA-F
- Status last verified
- Jul 2019
- First submitted
- 31 Aug 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Volfart A, Rossion B, Brissart H, Busigny T, Colnat-Coulbois S, Maillard L, Jonas J. Stability of face recognition abilities after left or right anterior temporal lobectomy. J Neuropsychol. 2024 Mar;18 Suppl 1:115-133. doi: 10.1111/jnp.12337. Epub 2023 Jun 30.
PubMed 37391874
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neuropsychological Effects of Drug-resistant Anterior Temporal Epilepsy and Anterior Temporal Lobectomy in Face Perception
- ClinicalTrials.gov ID
- NCT02888925
- Acronym / sponsor ID
- ATENA-F / 2013-A00515-40
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Mar 2020 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | Other | 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: LobectomyPatients 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 | Other | 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 testControl 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent
- Affiliation to social security
- Preliminary medical examination
- 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
Key exclusion criteria (8 listed)
- persons under legal protection or incapable to consent
- Persons deprived of liberty by juridical or administrative decision
- Sever visual disorders of neurological or ophthalmological origin
- Psychiatric or neurological disorders
- Important ophthalmological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mooney test | Other | Control, Epilepsy |
| Benton Face Recognition test | Other | Control, Epilepsy |
| Face inversion effect test | Other | Control, Epilepsy |
| Face composite effect test | Other | Control, Epilepsy |
| Cambridge Face Memory Test | Other | Control, Epilepsy |
| Matching different view test | Other | Control, Epilepsy |
| Memorizing and recognition of new faces test | Other | Control, Epilepsy |
| Memorizing and recognition of new objects test | Other | Control, Epilepsy |
| Recognition of celebrities and access to semantic information test | Other | Control, Epilepsy |
| LobectomyIn patients with anterior temporal epilepsy, at 6 to 12 months after inclusion, depending on surgery decision taken after pre-surgery conventional intercritical assessment | Procedure or surgery | Epilepsy |
Primary outcome
Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals
Time frame: day 0
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Derived from this study: PubMed 37391874Volfart A, Rossion B, Brissart H, Busigny T, Colnat-Coulbois S, Maillard L, Jonas J. Stability of face recognition abilities after left or right anterior temporal lobectomy. J Neuropsychol. 2024 Mar;18 Suppl 1:115-133. doi: 10.1111/jnp.12337. Epub 2023 Jun 30.
- Individual participant dataSharing planned: No
Related trials for Anterior Temporal Epilepsy
Recruiting
Pre-operative Mapping of the Anterior Temporal Lobe Using Functional MRI Innovative Techniques in in Drug-resistant Epileptic Patients
Epilepsy, Temporal Lobe, Cognitive Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Maillard principal investigator
Service de Neurologie, Hôpital Central, CHU de Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mooney test, Benton Face Recognition test and Face inversion effect test in people with Anterior Temporal Epilepsy and Anterior Temporal Lobectomy, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.