跳至主要内容
临床试验/NCT02844855
NCT02844855终止不适用

Memory for Action in Neurological Patients

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2016年12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
终止
入组人数
83
试验地点
2
主要终点
Number of correct answers

研究概览

简要总结

Memory for action is especially important in everyday life although current literature is not very abundant. The enactment effect (i.e. better memory for performed actions than for verbally encoded sentences) is usually described as a robust effect in aging and can be found in many diseases. Although the enactment effect has been studied for three decades, there is still no consensus on how it enhances memory. Therefore, in order to gain additional insight into the representational basis of the enactment effect, in the present study, the investigators propose to test neurological patients. The investigators suggested that memory for action should be better than memory for verbally encoded information in Alzheimer's disease and Parkinson's disease.

If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will perform the same tests to verify that they have no cognitive impairment. Then, two experimental conditions will be presented in all patients and controls: a first in which participants will have to name drawings (verbal learning) and a second in which they will have to reproduce an action associated with drawings (action learning). Immediately after this learning phase, a recognition task will be available and therefore participants will have to recognize drawings that had been presented previously. The main criteria used in the statistical analysis will be the correct recognition score.

详细描述

  1. = Folstein et al., 1975,
  2. = Zigmond & Snaith, 1983,
  3. = Dubois et al., 2002;
  4. = Godefroy et al., 2008;
  5. = Dubois et Pillon, 2000;
  6. = Mahieux-Laurent, 2009.

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
Basic Science
盲法
None

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for 3 arms:
  • •Patient affiliated to a social security system
  • •Age between 55 and 80 years
  • •Normal vision and hearing or successfully corrected
  • •French mother tongue
  • •Signature of consent by participants
  • •Specific criteria for inclusion of MA patients:
  • •Probable AD diagnosis made by a neurologist (McKhann et al., 2011)
  • •Mini-Mental State Examination (MMSE): score > 22
  • •Stable treatment for two months minimum.
  • •Specific criteria for inclusion of PD patients:
  • •PD diagnosed by a neurologist (Postuma et al., 2015)
  • •Stable treatment for two months minimum.
  • •Mini-Mental State Examination (MMSE): score > 27
  • •Under dopaminergic treatment

排除标准

  • •for 3 arms:
  • •Other neurological or psychiatric history
  • •Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)
  • •Inability to communicate
  • •Significant impairment of judgment
  • •Delusional or psychotic state
  • •Criteria common for non-inclusion of AD and PD patients:
  • •Other neurological or psychiatric history
  • •Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)
  • •Inability to communicate
  • •Significant impairment of judgment
  • •Delusional or psychotic state
  • •Criteria for non-inclusion of PD patients:
  • •Motor fluctuations
  • •Criteria for non-inclusion of controls:
  • •Psychiatric or neurological disorders
  • •Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)

研究组 & 干预措施

patients with Alzheimer disease

Active Comparator

Behavioral: Cognitive tests Only patients with Alzheimer disease will be included in this arm. Patients will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).

干预措施: Cognitive tests (Behavioral)

patients with Parkinson disease

Active Comparator

Behavioral: Cognitive tests Only patients with Parkinson disease will be included in this arm. Patients will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).

干预措施: Cognitive tests (Behavioral)

healthy controls

Sham Comparator

Behavioral: Cognitive tests Only patients with healthy controls will be included in this arm. Controls will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).

干预措施: Cognitive tests (Behavioral)

结局指标

主要结局

Number of correct answers

时间窗: Day 1

The gain provided by the verbal learning vs action learning (number of correct answers).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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