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临床试验/NCT06847152
NCT06847152已完成不适用

Spatial Memory and Temporal Lobe Epilepsy

Centre Hospitalier Metropole Savoie2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Changes of the number of correct responses from 1h to 6 weeks, compared between healthy volunteers and epileptic patients

研究概览

简要总结

Temporal lobe epilepsy (TLE) can cause memory disorders, including long-term forgetfulness due to a failure to consolidate verbal but also spatial information. The forgetting phenomenon presented by these epileptic patients is called accelerated forgetting in the literature and remains difficult to objectify during cognitive assessments. It is indeed particularly complicated to evaluate long-term spatial memory and to account for the topographical complaint, although recurrent, of patients with this TLE.

A navigation task being proposed as part of the neuropsychological assessment of patients with a spatial memory complaint, it is interesting to study the performance pattern of patients with TLE by comparing them to a group of control subjects matched in age and gender in order to verify whether there is significant long-term forgetting and whether there is a significant difference between Right TLE and Left TLE. Indeed, several studies have demonstrated this accelerated long-term forgetting in epileptic patients (Cassel et al., 2016; Lemesle et al., 2017; Landry et al., 2022; Blake et al., 2020) but few with a retention delay of several weeks (Tramoni et al., 2009). This study allows us to statistically analyze the effects of these two groups: epileptic patients and healthy volunteers, but also to combine the effect of the laterality of epilepsy specifically on spatial memory performance.

详细描述

In order to assess the long-term spatial memory capacities of epileptic patients with memory complaints, a navigation task was proposed as part of the neuropsychological assessment. This task corresponds to learning a route within the hospital. It is composed of a learning phase and then the patient is asked to repeat the route one hour later and then six weeks later, in order to check for the presence or absence of long-term forgetting. We wanted to study the results of patients with temporal lobe epilepsy (TLE) by comparing them to a group of healthy volunteers matched in age and gender in order to check whether there is significant long-term forgetting and whether there is a significant difference between Right TLE and Left TLE. This study therefore aims to statistically analyze the effects of these two groups: epileptic patients and healthy volunteers, but also to combine the effect of the laterality of epilepsy specifically on spatial memory performance. It will also be interesting to observe whether there is a difference between men and women in the healthy volunteer group for spatial memory learning.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - healthy volunteers meeting each of the following criteria:
  • Aged over 18 years
  • Right-handed*
  • Free of known neurological pathology
  • Signed consent
  • Matched in age (+ or - 5 years) and gender with epileptic patients presenting the characteristics below:
  • Right-handed*
  • presenting temporal lobe epilepsy, whose lateralization of the epileptogenic focus (right or left) has been objectified by an examination (EEG and/or MRI),
  • having carried out a neuropsychological assessment including the navigation task,
  • having been informed of the study, and consenting to the processing of their data

排除标准

  • Person referred to in Article L1121-5 of the Public Health Code: Pregnant, parturient, or breastfeeding women
  • Person referred to in Article L1121-6 of the Public Health Code: persons deprived of their judicial or administrative freedom
  • Person referred to in Article L1121-8 of the Public Health Code: persons subject to a legal protection measure or unable to express their consent
  • Person referred to in Article L1121-8-1 of the Public Health Code: persons not affiliated to a social security scheme
  • Left-handed participants
  • Participants familiar with the premises of the Centre Hospitalier Métropole Savoie
  • Not speaking French
  • Exclusion criteria
  • Patients who have undergone epilepsy neurosurgery between the initial visit and the secondary visit of the neuropsychological assessment will not be paired with a healthy volunteer. Their data will not be studied.
  • Volunteers whose pretest scores reveal a cognitive disorder (pathological threshold > 1.65) will not perform the navigation task. They will then be referred to a neurologist.

研究组 & 干预措施

Healthy participant

Experimental

spatial memory test to healthy participant

干预措施: spatial memory test (Diagnostic Test)

Epileptic patient

Experimental

spatial memory test to epileptic patient

干预措施: spatial memory test (Diagnostic Test)

结局指标

主要结局

Changes of the number of correct responses from 1h to 6 weeks, compared between healthy volunteers and epileptic patients

时间窗: 1 hour and 6 weeks

The number of correct responses is defined as the number of intersections correctly crossed.

次要结局

  • Changes in test performance from 1h to 6 weeks, compared according to epileptogenic focus (right or left) lateralization.(at 1 hour and 6 weeks.)
  • Changes in test performance from 1h to 6 weeks, compared between male and female in the healthy volunteers group(at 1 hour and 6 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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