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Epilepsy, Temporal LobeCARTANCT05339438

Pre-operative Mapping of the Anterior Temporal Lobe Using Functional MRI Innovative Techniques in in Drug-resistant Epileptic Patients

A study testing functional MRI in people with Epilepsy, Temporal Lobe and Cognitive Decline, run by Central Hospital, Nancy, France at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Anterior temporal epilepsy is the most frequent form of focal epilepsy (more than 50% of focal epilepsies). The epilepsy is drug-resistant when epileptic seizures persist despite antiepileptic treatment (25% of cases). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Epilepsy, Temporal Lobe, Cognitive Decline
What is being tested?
functional MRI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
10 Jun 2022to 9 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Adult person,
  • Person affiliated to a social security scheme or beneficiary of such a scheme,
  • Person having received complete information on the organization of the Clinical Investigation and having signed informed consent,
  • Person having carried out a preliminary clinical examination adapted to the Clinical Investigation,
  • For patients: Person with drug-resistant structural focal epilepsy of the anterior temporal lobe (right or left), candidate for epilepsy surgery (anterior temporal lobectomy),
  • For healthy volunteers: Person with no known pathology in the anterior temporal lobe (particularly epilepsy).

Who cannot join

  • Contraindication to MRI including claustrophobia,
  • Uncorrected visual disturbances,
  • Person unable to give consent,
  • Lack of mastery of the French language or ability to understand instructions,
  • Person referred to in Articles 64, 65 and 66 of European Regulation 2017/745: Person of full age unable to consent alone to participate in the Clinical Investigation; Minor; Pregnant or breastfeeding woman.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Centre Hospitalier Régional Universitaire de Nancy

    Nancy

    Jacques JONAS, MI

    Recruiting

Other trials in France

About this study

Anterior temporal epilepsy is the most frequent form of focal epilepsy (more than 50% of focal epilepsies). The epilepsy is drug-resistant when epileptic seizures persist despite antiepileptic treatment (25% of cases). In this case, it is possible to offer a surgical solution to the patient: an anterior temporal lobectomy. This surgery consists of removing the entire portion of the temporal lobe responsible for epilepsy (epileptogenic zone), that is to say a major part of the temporal pole, the hippocampus and the ventral anterior temporal lobe (vATL). The goal of the surgery is to lead to a disappearance of the seizures while preserving the functions of the patient. This is why a pre-surgical assessment is systematically carried out in order to locate the epileptic focus and to predict the risks of neurological and cognitive deficits. The vATL is of particular interest because it is a highly functional region, involved in naming, semantic processing and face recognition. A resection of this region by anterior lobectomy can therefore impact these functions and lead to cognitive deficits (for example, up to 65% decline in naming), which can be disabling in the lives of patients, even if they are free from seizures. One of the major challenges of epilepsy surgery is therefore to predict the postoperative neuropsychological outcome. The prediction of the neuropsychological outcome of the post-surgery patient is largely based on the mapping of functional regions preoperatively, carried out by functional MRI (fMRI), or by electrical stimulation carried out during intracerebral exploration by StereoElectroEncephalography (SEEG).

However, current techniques have drawbacks. Electrical stimulations are based on an invasive exploration (SEEG), are time-consuming and sometimes difficult to interpret. The fMRI sequences used in clinical routine do not make it possible to visualize the entire vATL region because of artifacts related to the auditory canal. Thus, the signal is strongly diminished in this region, rendering a large area of the vATL invisible. This results in insufficient visualization of activated vATL regions when performing tasks such as naming, semantic processing, and face recognition. Important functional regions can therefore be removed during surgery and negatively impact the patient's neuropsychological outcome.

Read more

In the CARTA study, original methods are associated in order to increase the signal-to-noise ratio in vATL. On the one hand, the Multi-Band sequence, an innovative fMRI sequence, will be used. On the other hand, a particular method of presentation of visual stimuli will be used, called fast periodic visual stimulation (FPVS: Fast Periodic Visual Stimulation), during which the stimuli are presented periodically (fixed frequency). Individually, these methods improve vATL (signal enhancement) exploration. The investigators assume that the combination of the two methods may have a potentiating effect, compared to the standard SMS (Simultaneous Multi-Slice) sequence. fMRI exploration will not influence the surgical management of the patient included in the study because it is the beginning of the development of this technique, but could be used, in the longer term, to guide the surgeries of epileptic patients.

Thus, the goal of this study is to precisely map the vATL, using innovative methods in fMRI. This mapping will make it possible to study the cerebral functions of the vATL involved in naming, semantic processing and face recognition, and ultimately improve the postoperative neuropsychological prognosis of epileptic patients.

Being tested
functional MRI
Medical subject headings
Epilepsy, Temporal Lobe, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • functional MRIRadiation

    Functional MRI scanning (around 1h30 min): SMS + multi-band (with FPVS paradigms for both)

Study groups in NCT05339438
Study groupRoleWhat they receive
Epileptic patientsExperimentalEpileptic patients with anterior temporal lobe epilepsy
Receives: Radiation: functional MRI
Healthy volunteersExperimentalHealthy volunteers
Receives: Radiation: functional MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Anterior Temporal Lobe activity

    Blood Oxygen Level Dependent (BOLD) measures for each task (naming, semantic processing, and face recognition)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start10 Jun 2022
  3. Primary completion9 Jun 2027 (estimated)
  4. Study completion9 Jun 2027 (estimated)

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05339438
Sponsor's protocol ID
2021-A02968-33
Acronym
CARTA
Status last verified
Jun 2025
First submitted
6 Apr 2022
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Visser M, Lambon Ralph MA. Differential contributions of bilateral ventral anterior temporal lobe and left anterior superior temporal gyrus to semantic processes. J Cogn Neurosci. 2011 Oct;23(10):3121-31. doi: 10.1162/jocn_a_00007. Epub 2011 Mar 10.

    PubMed 21391767
  • Jonas J, Jacques C, Liu-Shuang J, Brissart H, Colnat-Coulbois S, Maillard L, Rossion B. A face-selective ventral occipito-temporal map of the human brain with intracerebral potentials. Proc Natl Acad Sci U S A. 2016 Jul 12;113(28):E4088-97. doi: 10.1073/pnas.1522033113. Epub 2016 Jun 27.

    PubMed 27354526
  • Jonas J, Rossion B, Brissart H, Frismand S, Jacques C, Hossu G, Colnat-Coulbois S, Vespignani H, Vignal JP, Maillard L. Beyond the core face-processing network: Intracerebral stimulation of a face-selective area in the right anterior fusiform gyrus elicits transient prosopagnosia. Cortex. 2015 Nov;72:140-155. doi: 10.1016/j.cortex.2015.05.026. Epub 2015 Jun 4.

    PubMed 26143305
  • Puckett AM, Bollmann S, Poser BA, Palmer J, Barth M, Cunnington R. Using multi-echo simultaneous multi-slice (SMS) EPI to improve functional MRI of the subcortical nuclei of the basal ganglia at ultra-high field (7T). Neuroimage. 2018 May 15;172:886-895. doi: 10.1016/j.neuroimage.2017.12.005. Epub 2017 Dec 5.

    PubMed 29208571
  • Gao X, Gentile F, Rossion B. Fast periodic stimulation (FPS): a highly effective approach in fMRI brain mapping. Brain Struct Funct. 2018 Jun;223(5):2433-2454. doi: 10.1007/s00429-018-1630-4. Epub 2018 Mar 3.

    PubMed 29502144

Questions about this trial

What is this clinical trial studying?

A study testing functional MRI in people with Epilepsy, Temporal Lobe and Cognitive Decline, 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacques JONAS (+33383852377, j.jonas@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Anterior Temporal Lobe activity (time frame: 3 years). 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 NCT05339438, which also lists 5 linked publications.

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 1 Jul 2025.

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