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临床试验/NCT03686839
NCT03686839已完成不适用

Importance of Exploring Feasibility and Acceptability in Application of EEG Neurofeedback in Older Adults With Mild Cognitive Impairment

Fabienne Marlats2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年3月3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
发起方
入组人数
22
试验地点
2
主要终点
Neurofeedback Technology Acceptation Questionnaire

研究概览

简要总结

This is a non-pharmacological study evaluating the feasibility of a neurofeedback training program in elderly with mild cognitive impairment (MCI) according to recruitment, retention, attendance, acceptability data.

详细描述

Neurofeedback (NF) can be counted amongst promising techniques to improve cognitive functioning if the principles of application are seriously respected, whilst recognizing the necessary adaptation to the conditions of patients with Mild Cognitive Impairment (MCI). This study examined the feasibility and acceptability of an electroencephalography neurofeedback training protocol in a sample group of older adults with MCI in order to identify the necessary conditions for an improved neurofeedback application. Participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T2) and 1-month follow-up (T3). A questionnaire about motivation, opinions of technical aspects of NF and feeling of cognitive improvement was administered at T0 and T2.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Clinical diagnosis of Mild Cognitive Impairment
  • Absence of history of alcohol or other substance consumption

排除标准

  • Psychiatric and neurological disorders
  • sensory and/or motor deficit.
  • involving in another cognitive intervention

研究组 & 干预措施

SMR neurofeedback training to MCI

Experimental

Sensorimotor rhythm neurofeedback protocol consisted of 20 individual sessions, twice a week, during 11 weeks maximum. For each subject MCI, NF was planned and conducted by a neuropsychologist experienced in neurophysiology and neurofeedback. Each session lasted 1h10-15min and was conducted as follows:

  1. Preparation and installation of the electrodes, verification of the impedance, adjustment of the calibration and thresholds (15 minutes).
  2. NF training (tasks and video described below) (45 minutes).
  3. Feedback and debriefing about the session (15 minutes).

干预措施: SMR neurofeedback training to MCI (Behavioral)

结局指标

主要结局

Neurofeedback Technology Acceptation Questionnaire

时间窗: Assessment was at 2 months immediately after the Neurofeedback intervention

Neurofeedback Technology Acceptation Questionnaire assessed the participants' opinions face to the electroencephalography neurofeedback intervention with 33 questions. The mode of administration was a personal interview with the investigator, the type of questions was closed-ended (for binary variable yes or no). Answers were analyzed with the Multiple Correspondence Analysis to visualize associations and similarities among participants and answers to Questionnaire. An unsupervised hierarchical clustering was performed using the Euclidean distance and Ward's method. Clusters were defined graphically using dendrogram.

次要结局

未报告次要终点

研究者

发起方
Fabienne Marlats
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fabienne Marlats

Neuropsychologist

Broca Hospital

研究点 (2)

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