跳至主要内容
临床试验/NCT07191197
NCT07191197招募中不适用

New Semantic Learning in Patients With Selective Brain Lesions in Temporal Regions: a Behavioural and MRI Study

University Hospital, Toulouse4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
4
主要终点
Performance on Fast-Mapping semantic learning task

研究概览

简要总结

THE STUDY AIMS to constitute the largest group of patients with major memory impairment resulting from various etiology and specific lesions of the medial temporal lobe (MTL) and use a combined psychometric and neuroimaging approach to study the factors allowing these patients to successfully learn new semantic information.

详细描述

The preservation of learning abilities is an essential aspect in the implementation of cognitive rehabilitation programs for patients with an amnesic syndrome. Particularly disabled on a daily basis, these patients have significant difficulties in coping with the demands of work and family life. Data from previous case studies attest to the ability of these patients to rely on preserved cognitive systems to learn new semantic information. However, the procedures for the acquisition of new information are sometimes long, not optimal and the clinical factors, that can influence it, are poorly identified. In addition, the brain networks necessary for such learning are still debated. In order to better understand the cognitive mechanisms and brain networks that underlie the ability to learn new semantic information, the research aims to study a group of patients with major memory impairment following medial temporal lobe lesions of various etiologies (non-degenerative). The study will use a combined psychometric and neuroimaging approach to identify the factors that enable these patients to successfully learn new semantic information.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 70 years
  • Living in France since less than 20 years, being able to understand the French language, and have basic cultural knowledge as evaluated in classical clinical consultation
  • Written agreement to participate in the study
  • Intellectual capacities compatible with the cognitive tasks and signing of consent
  • Affiliation to the French social security system
  • For patients: bilateral brain lesion of the medial temporal lobe or the extended hippocampal system

排除标准

  • Subjects under the age of 18 or over 70
  • Contraindications for MRI (examples: wearers of a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, wearers of haemostatic clips for intracerebral aneurysms or carotid arteries, wearers of orthopedic implants, claustrophobic)
  • Refusal to be informed of an anomaly detected during the MRI

研究组 & 干预措施

Learning abilities for Patients with an amnesic syndrome

Experimental

1 MRI session, 2 cognitive research tasks of semantic learning, and neuropsychological assessment.

干预措施: MRI (Other)

Learning abilities for Patients with an amnesic syndrome

Experimental

1 MRI session, 2 cognitive research tasks of semantic learning, and neuropsychological assessment.

干预措施: Psychometric (Other)

Healthy controls

Active Comparator

To allow multiple pairing for each patient, a group of 120 healthy controls aged between 18 to 70 years old will be recruited. Thus, it will be possible to compare one given patient to a group of 40 aged-matched subjects.

All healthy volunteers will undergo the same intervention as the patients :

1 MRI session, 2 cognitive research tasks of semantic learning, neuropsychological assessment.

干预措施: MRI (Other)

Healthy controls

Active Comparator

To allow multiple pairing for each patient, a group of 120 healthy controls aged between 18 to 70 years old will be recruited. Thus, it will be possible to compare one given patient to a group of 40 aged-matched subjects.

All healthy volunteers will undergo the same intervention as the patients :

1 MRI session, 2 cognitive research tasks of semantic learning, neuropsychological assessment.

干预措施: Psychometric (Other)

结局指标

主要结局

Performance on Fast-Mapping semantic learning task

时间窗: Baseline

* MRI measures: Anatomical MRI (T1-weighted) images will be analyzed using voxel-based lesion-symptom mapping (VLSM, MATLAB toolbox). Voxels will be classified as "lesioned" or "non-lesioned" in gray and white matter. * Behavioral measures: Performance on fast-mapping tasks (recognition scores). Those measurements will be aggregated : VLSM will be used to generate statistical maps of significant differences in fast-mapping recognition scores between lesioned vs. non-lesioned voxels across the T1 MRI. This method allows the evaluation of statistical relationships between specific brain lesions and behavioral deficits without requiring patient grouping by lesion site or behavioral threshold. VLSM integrates permutation testing for robust statistical inference and can analyze both discrete and graded lesions. As voxels may be located in either cortical or white matter regions, the approach enables the investigation of disconnection syndromes in addition to cortical syndromes.

次要结局

  • Performance of semantic learning(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验