Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 12
- 主要终点
- Effect of rehabilitation on immediate postoperative performances
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Effect of rehabilitation on immediate postoperative performances
时间窗: Day 7 after surgery
Number of images quoted
次要结局
- Lexical fluency(6 months after surgery)
- Impact of rehabilitation on long-term postoperative performance on standardized language tests(6 months after surgery)
- Impact of rehabilitation on immediate on standardized language tests(Day 7 after surgery)
- Impact of preoperative rehabilitation on verbal memory(6 months after surgery)
- Evaluation of Quality of life(6 months after surgery)
- Impact of rehabilitation on long-term postoperative performance(6 months after surgery)
- Denomination of control lists(6 months after surgery)
- Self-reported perception of anomia(6 months after surgery)
- Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions(6 months after surgery)