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临床试验/NCT01454557
NCT01454557Unknown不适用

The Effect of Auditory Stimuli on Heart Rate Variability (HRV) During Resting and During Physical Activity Among Patients With Acquired Brain Injury (ABI)

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Heart Rate Variability

研究概览

简要总结

Heart Rate Variability (HRV) reflects the responsiveness of the autonomic system to an external stimuli. The aim of this system is to maintain homeostasis.The variability implies on the interaction between the sympathetic and the parasympathetic systems to maintain the ongoing changes of the autonomic system. Following Acquired Brain Injury (ABI), there can be a damage to the Central Nervous System (CNS) function. The damages described in the literature are cognitive, motor and behavioural function, while there is less relation to the autonomic system. The autonomic system can influence the ability of patient with ABI to participate in the rehabilitation program. The aim of this work is to investigate the activity of the autonomic system activity as manifested by HRV among patients with ABI in different conditions: resting, during activity and while listening to different auditory stimuli.

研究设计

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

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

  • 2-4 months from acceptance to rehabilitation medical stable

排除标准

  • medical unstable a significant hearing deficit premorbid neurological or mental condition

结局指标

主要结局

Heart Rate Variability

时间窗: first measurement: 2 weeks to 2 months from hospitalization to the department: 24 hours EKG follow up for HRV base line. Last measurement: before the release from rehabilitation (up to 12 months).

Heart Rate Variability as measured by HOLTER EKG during the 4 different conditions: first measuerement 2-8 weeks from hospitalization in the TBI rehabilitation department-24 hours detection for HRV baseline. Second measurement: a week after: EKG during the 4 conditions. Third measurement:a month after the first measure, Fourth measurement: 2 months after the first one. Last measurement: Before the release home from rehabilitation (up to one year from the first measurement).

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Ofer Keren

The head of the TBI rehabilitation department

Sheba Medical Center

研究点 (1)

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