Preoperative speech rehabilitation for patients with drug-resistant temporal epilepsy

Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

This study is testing a speech therapy program for people with drug-resistant temporal lobe epilepsy to see if it can help improve their thinking and memory skills before they have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (Academic / other)
• Locations: 12 sites (Bordeaux and 11 other locations)
• Trial ID: NCT05609084 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with drug-resistant temporal lobe epilepsy who are candidates for neurosurgery. It aims to implement a specific speech rehabilitation program designed to improve cognitive functions, particularly lexical access and verbal memory, prior to surgical intervention. The approach is based on cognitive theories and models of neural plasticity, with the goal of enhancing cognitive reserve and potentially mitigating postoperative cognitive difficulties. Participants will undergo speech therapy assessments and interventions tailored to their needs.

Who should consider this trial

Good fit: Ideal candidates are patients aged 16 and older with drug-resistant temporal lobe epilepsy involving the language-dominant hemisphere.

Not a fit: Patients whose epilepsy is not drug-resistant or who do not have a language-dominant hemisphere involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve cognitive outcomes and quality of life for patients undergoing surgery for temporal lobe epilepsy.

How similar studies have performed: While there is limited research on preoperative cognitive rehabilitation in this specific context, similar approaches in other neurological conditions have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Patient 16 years of age and older,
2. Patient whose epileptogenic area involves the temporal structures of the hemisphere specialized for language,
3. Patient whose hemispheric specialization for language is known
4. Patient willing to undergo resective surgery such as anterior temporal lobectomy or resection in the temporal lobe involving the hippocampus and/or the baso-temporal language area and whose planned surgery date is compatible with the performance of the study,
5. Patient with a known NTB score
6. Patient who has signed an informed consent or patient whose parents or legal guardians have signed the informed consent (or a single parent or legal guardian if applicable)
7. Patient whose first language is French (1st language learned by the patient),
8. Patient declaring to be familiar with the use of a computer and having access to an internet connection from home
9. Patient affiliated or benefiting from a social security system.

Exclusion Criteria:

1. Patient with a speech disorder that may impair intelligibility and compromise the use of the interface;
2. Patient with an uncorrected hearing impairment,
3. Patients with a total intelligence quotient (IQ) \<70 (assessed in the context of care, in the year preceding the surgical procedure)
4. Patients who are pregnant, nursing, deprived of liberty, under guardianship or curatorship.

Where this trial is running

Bordeaux and 11 other locations

• Service EFSN - Hôpital Pellegrin — Bordeaux, France (Recruiting)
• Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes — Grenoble, France (Recruiting)
• Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille — Lille, France (Recruiting)
• Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon — Lyon, France (Not_yet_recruiting)
• Service Epilptologie et Rythmologie Cérébrale — Marseille, France (Recruiting)
• Service de Neurologie - Hôpital central -CHU Nancy — Nancy, France (Not_yet_recruiting)
• Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP — Paris, France (Not_yet_recruiting)
• Service de Neurochirurgie -GHU Sainte-Anne — Paris, France (Not_yet_recruiting)
• Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild — Paris, France (Recruiting)
• Service de Neurologie - CHU de Rennes — Rennes, France (Not_yet_recruiting)
• Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre — Strasbourg, France (Recruiting)
• Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan — Toulouse, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Veronique Sabadell

Conditions Epilepsy; Anomia; Temporal Lobe Epilepsy