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临床试验/NCT03263247
NCT03263247进行中(未招募)不适用

Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.

São Paulo State University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Changes in functional magnetic resonance imaging (fMRI)

研究概览

简要总结

The current project aims to investigate the trajectories of the visual imaging cognitive training (CT) and alphabet search training using fMRI in patients with amnestic mild cognitive impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to biomarkers (PET PIB).

详细描述

We will include 40 subjects with amnestic mild cognitive impairment (MCI) multiple domain clinical diagnostic, over 60 years old, recruited through the outpatient clinic of University of Sao Paulo General Hospital. We will also include 20 healthy subjects, over 60 years old, recruited in the community. All the participants will be evaluated by neurologists specialized in cognitive neurology and subjected to a neuropsychological assessment. The 40 participants with MCI and 20 healthy subjects will receive 6 sessions of visual imaging training. After this first study, they will receive cognitive training with alphabet search training. This will be a longitudinal study. MCI patients will be grouped according to biomarkers (PET PIB).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Portuguese as native and preferred language; A minimum of 4 years of education; MRI-compatible; Right-handed individuals; Normal corrected vision and hearing; Estimated intelligence average or above (≥ 80 IQ);

排除标准

  • History of neurological disorder, severe mental illness; Current untreated alcohol or substance abuse; Medical conditions that compromise in any way the central nervous system; Presence of visual impairment and / or hearing to preclude cognitive testing; Presence of contraindications to MRI exam; Findings in structural MRI that can interfere with the results of the study

研究组 & 干预措施

Visual Imaging Training

Experimental

Participants will receive visual imaging training to facilitate learning of written information.

Intervention: Visual Imaging Training in individual sessions

干预措施: Memory Training (Behavioral)

Psychoeducation

Active Comparator

Participants will receive information about memory functioning and aging.

Intervention: behavioral: Psychoeducation in individual sessions

干预措施: Psychoeducation (Behavioral)

Alphabet Search

Experimental

Participants will receive alphabet search training.

Intervention: Alphabet Search in individual sessions

干预措施: Alphabet search (Behavioral)

结局指标

主要结局

Changes in functional magnetic resonance imaging (fMRI)

时间窗: Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance

fMRI correlates of behavioral performance

Changes in memory and language measures

时间窗: Baseline and after 4 weeks of intervention - generalization

Improvement in Logical Memory Test I and II results and naming tests

Results from task performance in functional magnetic resonance imaging (fMRI)

时间窗: Baseline, after CT, and 12 months later

fMRI behavioral performance

次要结局

  • Changes in perception of memory performance(Baseline, within four weeks after intervention)
  • Changes in cognitive measures and brain activation(Baseline, after CT e 12 months follow-up)

研究者

发起方
São Paulo State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eliane Mioto

Prof. Dr Eliane C Miotto

São Paulo State University

研究点 (2)

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