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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05609084
Other study ID # 2021-17
Secondary ID ID-RCB
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2023
Est. completion date November 30, 2025

Study information

Verified date November 2023
Source Assistance Publique Hopitaux De Marseille
Contact Veronique Sabadell
Phone 0491385298
Email veronique.sabadell@ap-hm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 214
Est. completion date November 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 who accepts resective surgery such as anterior temporal lobectomy and whose planned surgery date is compatible with 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


Intervention

Procedure:
Speech therapy
Patients will connect on an interface to pratice speech therapy
Speech therapy assessment
Patients will be followed by an speech therapist

Locations

Country Name City State
France 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 Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon Lyon
France Service Epilptologie et Rythmologie Cérébrale Marseille
France Service de Neurologie - Hôpital central -CHU Nancy Nancy
France Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP Paris
France Service de Neurochirurgie -GHU Sainte-Anne Paris
France Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild Paris
France Service de Neurologie - CHU de Rennes Rennes
France Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre Strasbourg
France Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of rehabilitation on immediate postoperative performances Number of images quoted Day 7 after surgery
Secondary Impact of rehabilitation on long-term postoperative performance Number of images quoted 6 months after surgery
Secondary Impact of rehabilitation on immediate on standardized language tests % of correct answers of language tests Day 7 after surgery
Secondary Impact of rehabilitation on long-term postoperative performance on standardized language tests % of correct answers of language tests 6 months after surgery
Secondary Impact of preoperative rehabilitation on verbal memory Verbal memory task Day 7 after surgery
Secondary Impact of preoperative rehabilitation on verbal memory Verbal memory task 6 months after surgery
Secondary Lexical fluency Lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion Day 7 after surgery
Secondary Lexical fluency lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion 6 months after surgery
Secondary Denomination of control lists Number of words quoted Day 7 after surgery
Secondary Denomination of control lists Number of words quoted 6 months after surgery
Secondary Self-reported perception of anomia Use of an ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint) Day 7 after surgery
Secondary Self-reported perception of anomia Ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint) 6 months after surgery
Secondary Evaluation of Quality of life Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome) Day 7 after surgery
Secondary Evaluation of Quality of life Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome) 6 months after surgery
Secondary Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions Number of speech therapy sessions performed postoperatively 6 months after surgery
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