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临床试验/NCT04300933
NCT04300933已完成不适用

Effects of Electroencephalogram-based Neurofeedback on Cognition in Adults With Subject Cognitive Decline

XuanwuH 21 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Changes of Auditory Verbal Learning Test (AVLT) score

研究概览

简要总结

Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective pharmacologic therapy for this disease. Electroencephalogram-based neurofeedback is considered as a potentially treatment strategy. In this project, the investigators aim to investigate the effectiveness of neurofeedback therapy on cognition for individuals with subjective cognitive decline (SCD). Participants will receive electroencephalogram-based neurofeedback therapy once a day for successive five days. Then, the investigators will evaluate the changes of memory function between baseline and post-therapy visits.

详细描述

Currently, there has been no effective therapy for Alzheimer's disease (AD). Electroencephalogram-based neurofeedback is now considered as a potentially intervention and may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of neurofeedback on cognition for subjective cognitive decline (SCD).

Fifty participants with SCD will be recruited in this clinical trial. At baseline, neuropsychological tests are conducted. Participants will receive electroencephalogram-based neurofeedback therapy once a day for successive five days. After that, the investigators will evaluate the changes of memory measures, which is the primary outcome.

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
50 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50-79 years old, right-handed and Mandarin-speaking subjects;
  • self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event;
  • normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests;
  • concerns (worries) associated with memory complaint;
  • failure to meet the criteria for MCI or dementia

排除标准

  • a history of stroke;
  • major depression (Hamilton Depression Rating Scale score > 24 points);
  • other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
  • cognitive impairment caused by traumatic brain injury;
  • systemic diseases, such as thyroid dysfunction, syphilis and HIV;
  • a history of psychosis or congenital mental growth retardation.

结局指标

主要结局

Changes of Auditory Verbal Learning Test (AVLT) score

时间窗: Five days

After intervention for five days, the investigators will compare baseline and post-therapy memory changes based on Auditory Verbal Learning Test (AVLT) scale, in order to investigate the therapeutic effectiveness of neurofeedback. The scale of AVLT focuses on the memory domain, especially AVLT-long delayed memory, with cut- off points as 5 (50-59 years old), 4 (60-69 years old), 3 (70-79 years old) and AVLT-recognition, with cut-off points as 20 (50-59 years old), 19 (60-69 years old), 18 (70-79 years old). Higher scores mean a better outcome.

次要结局

未报告次要终点

研究者

发起方
XuanwuH 2
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

XuanwuH 2

Professor

Xuanwu Hospital, Beijing

研究点 (1)

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