MedPath

Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Not Applicable
Recruiting
Conditions
Temporal Lobe Epilepsy
Anomia
Epilepsy
Interventions
Procedure: Speech therapy
Procedure: Speech therapy assessment
Registration Number
NCT05609084
Lead Sponsor
Assistance Publique Hopitaux De Marseille
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
214
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ExperimentalSpeech therapyPatients will have speech therapy assessment and intensive speech rehabilitation
ExperimentalSpeech therapy assessmentPatients will have speech therapy assessment and intensive speech rehabilitation
ControlSpeech therapy assessmentPatients will have speech therapy assessment in addition to standard care.
Primary Outcome Measures
NameTimeMethod
Effect of rehabilitation on immediate postoperative performancesDay 7 after surgery

Number of images quoted

Secondary Outcome Measures
NameTimeMethod
Lexical fluency6 months after surgery

lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion

Impact of rehabilitation on long-term postoperative performance on standardized language tests6 months after surgery

% of correct answers of language tests

Impact of rehabilitation on immediate on standardized language testsDay 7 after surgery

% of correct answers of language tests

Impact of preoperative rehabilitation on verbal memory6 months after surgery

Verbal memory task

Evaluation of Quality of life6 months after surgery

Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome)

Impact of rehabilitation on long-term postoperative performance6 months after surgery

Number of images quoted

Denomination of control lists6 months after surgery

Number of words quoted

Self-reported perception of anomia6 months after surgery

Ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)

Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions6 months after surgery

Number of speech therapy sessions performed postoperatively

Trial Locations

Locations (12)

Service EFSN - Hôpital Pellegrin

🇫🇷

Bordeaux, France

Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes

🇫🇷

Grenoble, France

Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille

🇫🇷

Lille, France

Service de Neurologie - Hôpital central -CHU Nancy

🇫🇷

Nancy, France

Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon

🇫🇷

Lyon, France

Service Epilptologie et Rythmologie Cérébrale

🇫🇷

Marseille, France

Service de Neurochirurgie -GHU Sainte-Anne

🇫🇷

Paris, France

Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP

🇫🇷

Paris, France

Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild

🇫🇷

Paris, France

Service de Neurologie - CHU de Rennes

🇫🇷

Rennes, France

Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan

🇫🇷

Toulouse, France

Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre

🇫🇷

Strasbourg, France

© Copyright 2025. All Rights Reserved by MedPath