Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Last updated: July 17, 2024
Sponsor: Assistance Publique Hopitaux De Marseille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Communication Disorders

Seizure Disorders

Speech Disorders

Treatment

Speech therapy

Speech therapy assessment

Clinical Study ID

NCT05609084
2021-17
ID-RCB
  • Ages > 16
  • All Genders

Study 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

Inclusion Criteria:

  1. Patient 16 years of age and older,

  2. Patient whose epileptogenic area involves the temporal structures of the hemispherespecialized for language,

  3. Patient whose hemispheric specialization for language is known

  4. Patient willing to undergo resective surgery such as anterior temporal lobectomy orresection in the temporal lobe involving the hippocampus and/or the baso-temporallanguage area and whose planned surgery date is compatible with the performance ofthe study,

  5. Patient with a known NTB score

  6. Patient who has signed an informed consent or patient whose parents or legalguardians have signed the informed consent (or a single parent or legal guardian ifapplicable)

  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 aninternet connection from home

  9. Patient affiliated or benefiting from a social security system.

Exclusion

Exclusion Criteria:

  1. Patient with a speech disorder that may impair intelligibility and compromise theuse of the interface;

  2. Patient with an uncorrected hearing impairment,

  3. Patients with a total intelligence quotient (IQ) <70 (assessed in the context ofcare, in the year preceding the surgical procedure)

  4. Patients who are pregnant, nursing, deprived of liberty, under guardianship orcuratorship.

Study Design

Total Participants: 214
Treatment Group(s): 2
Primary Treatment: Speech therapy
Phase:
Study Start date:
March 30, 2023
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Service EFSN - Hôpital Pellegrin

    Bordeaux,
    France

    Active - Recruiting

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

    Grenoble,
    France

    Active - Recruiting

  • Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille

    Lille,
    France

    Active - Recruiting

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

    Lyon,
    France

    Site Not Available

  • Service Epilptologie et Rythmologie Cérébrale

    Marseille,
    France

    Active - Recruiting

  • Service de Neurologie - Hôpital central -CHU Nancy

    Nancy,
    France

    Site Not Available

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

    Paris,
    France

    Site Not Available

  • Service de Neurochirurgie -GHU Sainte-Anne

    Paris,
    France

    Site Not Available

  • Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild

    Paris,
    France

    Active - Recruiting

  • Service de Neurologie - CHU de Rennes

    Rennes,
    France

    Site Not Available

  • Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre

    Strasbourg,
    France

    Active - Recruiting

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

    Toulouse,
    France

    Site Not Available

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