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临床试验/NCT06768112
NCT06768112进行中(未招募)不适用

Adaptive Changes in Plasticity of Cerebrum and Cerebellum Following Innovative Postural

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
144
试验地点
1
主要终点
Cognitive Performance

研究概览

简要总结

This three-year research proposal aims to enhance postural control in older adults using non-invasive vagus nerve stimulation (nVNS). The study will develop a new system integrating cerebellar EEG (ECeG), EEG, and ECG to assess how nVNS combined with postural training affects individuals with early-stage frontal degeneration.

In the first year, the focus will be on creating and validating the ECeG system to explore neural mechanisms of postural control. The second year will test the combined effects of ear-nVNS and dynamic posture training, examining how nVNS influences adrenal and hormone pathways. The final year will evaluate if ear-nVNS can further improve postural training with virtual feedback.

Overall, the project aims to advance fall prevention strategies for older adults by exploring the role of cerebellar function and innovative training methods.

详细描述

The interaction between the cortex and cerebellum is pivotal in adapting to diverse postural challenges. Non-invasive vagus nerve stimulation (nVNS) has recently gained attention as a therapeutic approach with potential effects on frontal facilitation and improvement of neuromotor control. It provides a promising avenue to aid postural training for older individuals experiencing early-stage frontal degeneration. This three-year proposal aims to develop an integrated electrophysiological system for cerebellar EEG (ECeG), EEG, and ECG measures, with the goal of investigating the effects of innovative postural training with nVNS on older adults, particularly those at risk of falls due to frontal aging. The primary focus will be on the reorganization of cortical networks, the functional coupling between the cortex and cerebellum, and heart rate variability, with a contextual extension to the neurovisceral integrative model. In the first year, the proposal seeks to develop and validate a cerebellar electroencephalogram (ECeG) system, integrating it with the EEG and electrocardiogram (ECG) systems to explore the neural mechanisms for postural control on varying stance configurations for the elderly. During the second year, the proposal will investigate the effectiveness and neural mechanisms of combined ear-nVNS and dynamic posture training for the elderly, utilizing the Mesocircuit model to trigger adrenal and serum hormone pathways with nVNS. In the third year, the proposal will examine whether ear-nVNS can further enhance the postural training effects of virtual error amplification feedback in dynamic posture training for the elderly. The highlights of this project include the novel application of ear-nVNS to counteract falls in the elderly due to frontal degeneration and cognitive decline, as well as pioneering approaches to explore neural mechanisms underlying postural training effects with an in vivo examination of the cerebellar role. The innovative postural training with convenience is expected to be of practical value for fall prevention in the elderly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Age: Participants aged 18-45 years (young adults) and 60-80 years (older adults).
  • Vision should be within the normal range after visual correction.
  • Lower limb strength requirement: Ability to climb stairs without holding onto anything, able to ascend 15 steps (a typical office building floor has approximately 15-20 steps).
  • No history of falls in the past six months.

排除标准

  • Here is the translation of the provided text:
  • Young adult participants: Exclude students from the Department of Physical Therapy, School of Medicine, and Institute of Behavioral Medicine at National Cheng Kung University.
  • Uncontrolled cardiovascular diseases (e.g., hypertensive patients with resting systolic blood pressure exceeding 160 mmHg).
  • Lower limb venous embolism, arterial calcification, and lymphatic issues.
  • Diabetes, sickle cell anemia, coagulation disorders, dialysis patients, and those with conditions affecting walking, lower limb musculoskeletal function, and balance issues.
  • No known psychiatric, neuromuscular, or degenerative neurological diseases.
  • Hearing impairment or those using hearing aids.
  • Dizziness caused by any lesions.

结局指标

主要结局

Cognitive Performance

时间窗: the first day, at the end of 5 days training

Analysis of cognitive tests including Stroop test and trail making test.

Brain activity

时间窗: the first day, at the end of 5 days training

EEG Data Analysis

Kinematic Analysis of Upper and Lower Limb Dynamics

时间窗: the first day, at the end of 5 days training

Participants are asked to stand with both feet on a soft-pad and try to maintain a stable posture with minimal body sway. The center of pressure trajectory are taken to estimate behavioral and neurophysiological mechanisms. The dual-task involves performing simultaneous tasks of tapping LED sensor lights in real-time while standing on the soft-pad force plate.

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 (1)

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