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

February 21, 2024 updated by: Jacques JONAS, Central Hospital, Nancy, France

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nancy, France
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Nancy
        • Contact:
          • Jacques JONAS, MI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Radiation: functional MRI
Functional MRI scanning (around 1h30 min): SMS + multi-band (with FPVS paradigms for both)
Experimental: Epileptic patients
Epileptic patients with anterior temporal lobe epilepsy
Radiation: functional MRI
Functional MRI scanning (around 1h30 min): SMS + multi-band (with FPVS paradigms for both)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Anterior Temporal Lobe activity
Time Frame: 3 years
Blood Oxygen Level Dependent (BOLD) measures for each task (naming, semantic processing, and face recognition)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Estimated)

June 9, 2025

Study Completion (Estimated)

June 9, 2025

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02968-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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