Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2027-11-30

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.

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Detailed Description

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Conditions

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Epilepsy Anomia Temporal Lobe Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Patients will have speech therapy assessment in addition to standard care.

Group Type OTHER

Speech therapy assessment

Intervention Type PROCEDURE

Patients will be followed by an speech therapist

Experimental

Patients will have speech therapy assessment and intensive speech rehabilitation

Group Type EXPERIMENTAL

Speech therapy

Intervention Type PROCEDURE

Patients will connect on an interface to pratice speech therapy

Speech therapy assessment

Intervention Type PROCEDURE

Patients will be followed by an speech therapist

Interventions

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Speech therapy

Patients will connect on an interface to pratice speech therapy

Intervention Type PROCEDURE

Speech therapy assessment

Patients will be followed by an speech therapist

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francois CREMIEUX

Role: STUDY_DIRECTOR

AP-HM

Locations

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Service EFSN - Hôpital Pellegrin

Bordeaux, , France

Site Status RECRUITING

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

Grenoble, , France

Site Status RECRUITING

Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille

Lille, , France

Site Status RECRUITING