Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Conditions
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Epilepsy, Anomia, Temporal Lobe Epilepsy

Intervention / Treatment
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* Procedure: Speech therapy
* Procedure: Speech therapy assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 16 years of age and older, Patient whose epileptogenic area involves the temporal structures of the hemisphere specialized for language, Patient whose hemispheric specialization for language is known Patient who accepts resective surgery such as anterior temporal lobectomy and whose planned surgery date is compatible with the study, Patient with a known NTB score 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) Patient whose first language is French (1st language learned by the patient), Patient declaring to be familiar with the use of a computer and having access to an internet connection from home Patient affiliated or benefiting from a social security system. Exclusion Criteria: Patient with a speech disorder that may impair intelligibility and compromise the use of the interface; Patient with an uncorrected hearing impairment, Patients with a total intelligence quotient (IQ) <70 (assessed in the context of care, in the year preceding the surgical procedure) Patients who are pregnant, nursing, deprived of liberty, under guardianship or curatorship.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Patients will have speech therapy assessment in addition to standard care. | Procedure: Speech therapy assessment<br>* Patients will be followed by an speech therapist<br>|
| Experimental: Experimental<br>Patients will have speech therapy assessment and intensive speech rehabilitation | Procedure: Speech therapy<br>* Patients will connect on an interface to pratice speech therapy<br>Procedure: Speech therapy assessment<br>* Patients will be followed by an speech therapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of rehabilitation on immediate postoperative performances | Number of images quoted | Day 7 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of rehabilitation on long-term postoperative performance | Number of images quoted | 6 months after surgery | 
| Impact of rehabilitation on immediate on standardized language tests | % of correct answers of language tests | Day 7 after surgery | 
| Impact of rehabilitation on long-term postoperative performance on standardized language tests | % of correct answers of language tests | 6 months after surgery | 
| Impact of preoperative rehabilitation on verbal memory | Verbal memory task | Day 7 after surgery | 
| Impact of preoperative rehabilitation on verbal memory | Verbal memory task | 6 months after surgery | 
| Lexical fluency | Lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion | Day 7 after surgery | 
| Lexical fluency | lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion | 6 months after surgery | 
| Denomination of control lists | Number of words quoted | Day 7 after surgery | 
| Denomination of control lists | Number of words quoted | 6 months after surgery | 
| Self-reported perception of anomia | Use of an ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint) | Day 7 after surgery | 
| Self-reported perception of anomia | Ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint) | 6 months after surgery | 
| 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 | 
| 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 | 
| Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions | Number of speech therapy sessions performed postoperatively | 6 months after surgery |