Informations générales (source: ClinicalTrials.gov)

NCT05609084 En recrutement IDF
Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
Interventional
  • Épilepsie
  • Épilepsie temporale
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
mars 2023
novembre 2027
13 août 2025
Out of 30,000 new cases per year in France, 30% of epileptic patients are drug-resistant. Neurosurgery, which consists in resecting the epileptogenic zone, is the only chance of cure. In the case of temporal epilepsy of the language-dominant hemisphere (TLE), this procedure presents a high risk of increasing cognitive difficulties and may even be contraindicated for this reason alone. The difficulties found are impairments in lexical access (anomia) and verbal memory and affect more than 60% of patients . Preoperative cognitive rehabilitation could influence brain plasticity mechanisms but there are currently no recommendations on this topic. In this context, the investigators have developed a speech rehabilitation procedure specific to the needs of ELTPR patients. They rely on cognitive hypotheses explaining the disorders but also on models of rehabilitation-induced neural plasticity likely to improve cognitive reserve before surgery. The investigators hypothesize that preoperative cognitive language rehabilitation in ELTPR patients may decrease surgical risk and improve postoperative language prognosis. The primary objective is to demonstrate the protective efficacy of preoperative speech rehabilitation on language performance postoperatively.

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
HOPITAL FONDATION A. DE ROTHSCHILD Anca Nica En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP - Paris - France Vincent Navarro Recrutement non commencé Contact (sur clinicalTrials)
Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille - Lille - France Philippe Derambure En recrutement Contact (sur clinicalTrials)
Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan - Toulouse - France Marie Denuelle Recrutement non commencé Contact (sur clinicalTrials)
Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon - Lyon - France Alexandra Montavont Recrutement non commencé Contact (sur clinicalTrials)
Service de Neurochirurgie -GHU Sainte-Anne - Paris - France Elisabeth Landré Recrutement non commencé Contact (sur clinicalTrials)
Service de Neurologie - CHU de Rennes - Rennes - France Mihai Dragos-Millia Recrutement non commencé Contact (sur clinicalTrials)
Service de Neurologie - Hôpital central -CHU Nancy - Nancy - France Louis Maillard Recrutement non commencé Contact (sur clinicalTrials)
Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre - Strasbourg - France Edouard Hirsch En recrutement Contact (sur clinicalTrials)
Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes - Grenoble - France LORELLA MINOTTI En recrutement Contact (sur clinicalTrials)
Service EFSN - Hôpital Pellegrin - Bordeaux - France Véronique Michel En recrutement Contact (sur clinicalTrials)
Service Epilptologie et Rythmologie Cérébrale - Marseille - France Véronique Sabadell En recrutement Contact (sur clinicalTrials)

Critères

Tous
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.



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.