Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Effect of rehabilitation on immediate postoperative performances [Срок оценки: Day 7 after surgery]

Вторичные конечные точки (12)

• Impact of rehabilitation on long-term postoperative performance [Срок оценки: 6 months after surgery]
• Impact of rehabilitation on immediate on standardized language tests [Срок оценки: Day 7 after surgery]
• Impact of rehabilitation on long-term postoperative performance on standardized language tests [Срок оценки: 6 months after surgery]
• Impact of preoperative rehabilitation on verbal memory [Срок оценки: Day 7 after surgery]
• Impact of preoperative rehabilitation on verbal memory [Срок оценки: 6 months after surgery]
• Lexical fluency [Срок оценки: Day 7 after surgery]
• Lexical fluency [Срок оценки: 6 months after surgery]
• Denomination of control lists [Срок оценки: Day 7 after surgery]
• Denomination of control lists [Срок оценки: 6 months after surgery]
• Self-reported perception of anomia [Срок оценки: Day 7 after surgery]
• Self-reported perception of anomia [Срок оценки: 6 months after surgery]
• Evaluation of Quality of life [Срок оценки: Day 7 after surgery]

Критерии участия

Критерии включения

• 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 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,
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 12 центров

• Service EFSN - Hôpital Pellegrin — Bordeaux
• Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes — Grenoble
• Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille — Lille
• Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptolog — Lyon
• Service Epilptologie et Rythmologie Cérébrale — Marseille
• Service de Neurologie - Hôpital central -CHU Nancy — Nancy
• Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP — Paris
• Service de Neurochirurgie -GHU Sainte-Anne — Paris
• … и ещё 4 центра

Идентификаторы

NCT: NCT05609084 · 2021-17 · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗