跳至主要内容
临床试验/NCT04262674
NCT04262674Unknown不适用

Development of an Innovative, Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults

Empa, Swiss Federal Laboratories for Materials Science and Technology2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2019年9月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
82
试验地点
2
主要终点
Heart rate variability (HRV) indices SDNN and RMSSD with two-lead electrocardiogram chest belt

研究概览

简要总结

This project develops an innovative screening system and prediction model to detect preclinical symptoms of cognitive impairment and predict the potential development of mild cognitive impairments and dementia in older adults. The earliest possible detection of preclinical symptoms is prerequisite to improve the efficacy of subsequent preventative non-pharmacological, life-style and exercise related, personalized treatment interventions.

详细描述

BACKGROUND: Early detection of preclinical symptoms and prediction of potential development of mild cognitive impairment (MCI) and Alzheimer's disease (AD) could improve non-pharmacologic, life-style and exercise related preventative interventions' efficacy and slow-down disease progression. To achieve this goal, discriminating the earliest preclinical stage of MCI/AD from healthy state would be necessary. However, this is still challenging and current clinical methods are not feasible for preventative screening in larger populations of older adults, as they involve invasive sampling of molecular blood or cerebrospinal fluid biomarkers, as well as expensive brain imaging and extensive neuropsychological testing. Recently, several non-invasive alternative measures, including electroencephalography (EEG), gait analysis, heart rate variability (HRV), and core body temperature (Tc), were shown to be associated with preclinical symptoms of MCI/AD and to predict disease progression.

AIM: The investigators aim to combine these measures in a novel non-invasive multi-parameter prediction model, which better reflects multimodal symptomatology compared to currently used methods and, therefore, allows discriminating healthy persons from MCI state with adequate sensitivity (i.e. >80%).

METHODS: A cohort of 85 older adults, ≥65 years of age, including healthy persons and patients with MCI, will be recruited. Assessments will be performed at baseline, after 2 months (within these two 2 months one group will follow a cognitive-motor training intervention, while the other serves as passive control), and at 12-month follow-up. Assessments include EEG, gait analysis, HRV, and Tc at rest and during walking, and will be compared to reference measures of MCI status, including neuropsychological tests, to develop the prediction model and evaluate its sensitivity.

研究设计

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

入排标准

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

入选标准

  • participants have to be older than 65 years of age
  • cognitively healthy or diagnosed with MCI
  • able to walk at least 8 minutes for gait analysis, with or without walking aids
  • live independently or in a retirement home (classified 0, 1, or 2 within the Swiss classification system for health-care requirements BESA-levels [German abbreviation for: Bewohner-Einstufungs- und Abrechnungs-System; level 0 meaning the person does not need care or treatment; level 1 to 2 meaning, the person only needs little care or treatment])
  • sign informed consent

排除标准

  • previously diagnosed dementia, e.g. Alzheimer's disease
  • recent head injury
  • judgment by the participant's primary care physician will be required in the case of acute or instable chronic diseases (e.g. stroke, diabetes) and rapidly progressing or terminal illnesses
  • Additional exclusion criteria for the subgroup of 15 participants who would agree to take the telemetric gastrointestinal temperature pill:
  • history of operations and/or disease related to the gastrointestinal tract within last 5 years
  • implanted medical device
  • planned MRI examination
  • nausea, vomiting, constipation or abdominal pain within 1 months prior to the day of planned measurement

结局指标

主要结局

Heart rate variability (HRV) indices SDNN and RMSSD with two-lead electrocardiogram chest belt

时间窗: 10 minutes

The HRV indices SDNN (ms) and RMSSD (ms) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt.

Heart rate variability (HRV) index HF power with two-lead electrocardiogram chest belt

时间窗: 10 minutes

The HRV index HF power (ms\^2) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt.

Gait speed analysis with inertial sensors

时间窗: 15 minutes

The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, walking speed (m/s) will be assessed using inertial sensors attached to the feet.

Gait variability analysis with inertial sensors

时间窗: 15 minutes

The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, step length variability (%) and step time variability (%) will be assessed using inertial sensors attached to the feet.

Electroencephalography (EEG)

时间窗: 30 minutes

EEG frequency bands (Hz) will be assessed during 10 minutes at rest in a seated position (5 min eyes closed, 5 min eyes open) and will be recorded using a wearable system covering the frontal, parietal, temporal, and occipital cortex and integrating 20 gel-pad electrode channels. The assessment will be continued during the subsequent gait protocol which consists of 8 minutes of walking back and forth at preferred speed on a 20 m track.

Body temperature (T) with temperature sensors (thermistors)

时间窗: 30 minutes

T will be assessed under controlled climatic conditions (22°C/40% relative humidity) measuring skin T (°C) at the scapula and the the ribs (lateral) using temperature sensors (thermistors) during 10 minutes sitting and 8 minutes walking as described above.

次要结局

  • Cognitive performance with neuropsychological tests(1 hour)
  • Core body temperature (Tc) with telemetric gastrointestinal temperature pill(16 hours)

研究者

发起方
Empa, Swiss Federal Laboratories for Materials Science and Technology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick Eggenberger

Principal Investigator, Postdoc

Empa, Swiss Federal Laboratories for Materials Science and Technology

研究点 (2)

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