Clinical trial NCT05609084: Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
Official title: Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Anomia
Temporal Lobe Epilepsy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 214
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Effect of rehabilitation on immediate postoperative performances
timeFrame: Day 7 after surgery
Secondary outcomes:
measure: Impact of rehabilitation on long-term postoperative performance
timeFrame: 6 months after surgery
measure: Impact of rehabilitation on immediate on standardized language tests
timeFrame: Day 7 after surgery
measure: Impact of rehabilitation on long-term postoperative performance on standardized language tests
timeFrame: 6 months after surgery
measure: Impact of preoperative rehabilitation on verbal memory
timeFrame: Day 7 after surgery
measure: Impact of preoperative rehabilitation on verbal memory
timeFrame: 6 months after surgery
measure: Lexical fluency
timeFrame: Day 7 after surgery
measure: Lexical fluency
timeFrame: 6 months after surgery
measure: Denomination of control lists
timeFrame: Day 7 after surgery
measure: Denomination of control lists
timeFrame: 6 months after surgery
measure: Self-reported perception of anomia
timeFrame: Day 7 after surgery
measure: Self-reported perception of anomia
timeFrame: 6 months after surgery
measure: Evaluation of Quality of life
timeFrame: Day 7 after surgery
measure: Evaluation of Quality of life
timeFrame: 6 months after surgery
measure: Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service EFSN - Hôpital Pellegrin
city: Grenoble
country: France
facility: Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes
city: Lille
country: France
facility: Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille
city: Lyon
country: France
facility: Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon
city: Marseille
country: France
facility: Service Epilptologie et Rythmologie Cérébrale
city: Nancy
country: France
facility: Service de Neurologie - Hôpital central -CHU Nancy
city: Paris
country: France
facility: Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP
city: Paris
country: France
facility: Service de Neurochirurgie -GHU Sainte-Anne
city: Paris
country: France
facility: Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild
city: Rennes
country: France
facility: Service de Neurologie - CHU de Rennes
city: Strasbourg
country: France
facility: Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre
city: Toulouse
country: France
facility: Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan
Study officials:
affiliation: AP-HM
name: Francois CREMIEUX
role: STUDY_DIRECTOR
References: