Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

NCT05609084 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique Hopitaux De Marseille

Phase

Not applicable

Started

2023-03-30

Last updated

2024-07-18

Condition(s) studied

EpilepsyAnomiaTemporal Lobe Epilepsy

Investigational drug(s) / intervention(s)

Speech therapySpeech therapy assessment

Speech therapy: Patients will connect on an interface to pratice speech therapy

Speech therapy assessment: Patients will be followed by an speech therapist

Study summary

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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Effect of rehabilitation on immediate postoperative performances — Day 7 after surgery
Number of images quoted

Trial sites (12)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05609084 on ClinicalTrials.gov ↗ ← All trials in France