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临床试验/NCT07758257
NCT07758257已完成不适用

Esposoma: Biodiversità e Human Functioning Post Lesioni Vascolari Cerebrali Acquisite

Dr. Franco Molteni1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1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
30
试验地点
1
主要终点
Motor Measure

研究概览

简要总结

Grounded in the exposome framework and the bio-psycho-social model of health, this study investigated the effects of artificial light simulating natural sunlight on autonomic regulation, cognitive-motor performance and brain activity in 30 chronic stroke survivors. The aim of the study is to evaluate HRV and EEG recording across four successive conditions. Functional mobility and executive function, were evaluated before and after light exposure.

详细描述

The exposome encompasses the totality of environmental exposures, from light and pollutants to diet, stress and social relationships, and their associated biological responses (internal exposome) across an individual's entire lifetime. The neurovisceral integration model and a bio-psycho-social conception of health converge on a single insight: human functioning is the product of a continuously adaptive dialogue between the body's internal regulatory systems and the external environment, a perspective that places the exposome at the center of understanding human functioning.

More than 60% of stroke survivors experience persistent motor and cognitive impairments beyond six months post-stroke, accompanied by dysregulation of autonomic and circadian systems that collectively diminish quality of life and hinder rehabilitation.

Multisensory environmental stimulation, including exposure to both natural and artificial light, can reshape lifestyle and social dynamics in ways that sustain rehabilitation gains, in part by modulating the autonomic nervous system. Post-stroke dysautonomia, marked by reduced heart rate variability (HRV), sympathetic hyperactivation, and circadian disruption, is increasingly quantifiable through HRV indexes as a validated biomarker whose endogenous circadian rhythmicity is itself regulated by light via the suprachiasmatic nucleus. In fact, natural light synchronizes the human circadian system via melanopsin-expressing retinal ganglion cells that transmit signals to the suprachiasmatic nucleus, regulating melatonin, cortisol, sleep-wake cycles, autonomic tone and cortical activity. Through these interconnected pathways, light acts as a powerful biological modulator influencing circadian rhythms, HRV, vigilance, stress response and neuronal plasticity, making it a promising therapeutic tool in post-stroke rehabilitation. However, most rehabilitation patients spend the majority of their time indoors under standard artificial lighting that lacks the intensity, spectrum and dynamic variation of natural light, disrupting circadian regulation and potentially worsening recovery. Animal models further show that even low levels of nocturnal light exposure can increase ischaemic lesion size and cerebral inflammation, highlighting the vulnerability of the damaged brain to circadian light pollution. Human-centric LED lighting systems designed to replicate natural light dynamics have shown clinically meaningful results in post-stroke patients, with one randomized controlled trial reporting significant reductions in fatigue, depression and anxiety alongside restored circadian melatonin rhythmicity.

Despite promising clinical evidence, there is a critical gap in the literature: no study has simultaneously characterized the direct neurophysiological effects of lighting on autonomic regulation and cognitive-motor performances in chronic post-stroke patients.

The present study aims to fill this gap by investigating the effects of exposure to artificial lighting simulating natural light on heart rate variability parameters and on electroencephalographic activity in patients with chronic stroke, as well as to analyze whether the 15 minutes of light source induce changes in cognitive-motor outcomes.

研究设计

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

入排标准

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

入选标准

  • •Subjects with Cerebral Stroke, both ischemic and hemorrhagic, in either pediatric or adult age;
  • •Age > 18 years
  • •Absence of ongoing clinical acute conditions
  • •Able to provide written informed consent to participate in the study if of legal age, or consent from a legal representative if a minor
  • •Absence of major psychiatric disorders associated with the disability condition

排除标准

  • •Inability to provide informed consent
  • •Presence of other neurological conditions (e.g. Multiple Sclerosis, Parkinson's Disease…)
  • •Presence of ongoing clinical acute conditions
  • •Presence of major psychiatric disorders associated with the disability condition

研究组 & 干预措施

Light exposure

Experimental

Patients will be exposed to one single session of artificial light simulating the natural light

干预措施: Artificial Light (Device)

结局指标

主要结局

Motor Measure

时间窗: Pre and 10 minutes post light exposure

Timed Up and Go Test: TUG (lower values better performance)

次要结局

  • Motor Measure(Pre and 10 minutes post light exposure)
  • Cognitive Measure(Pre and 10 minutes post light exposure)
  • Biomarkers from ECG(Pre, during 15 minutes of light exposure (EXP), immediately after light exposure (POST1), 10 minutes after light exposure (POST2))
  • Biomarkers from blood sample(Pre, after light exposure (POST1), after 10 minutes of light exposure (POST2))
  • Biomarkers from saliva sample(Pre, after light exposure (POST1), 10 minutes after light exposure (POST2))
  • Biomarkers from EEG data(Pre, during 15 minutes of light exposure (EXP), immediately after light exposure (POST1), 10 minutes after light exposure (POST2))

研究者

发起方
Dr. Franco Molteni
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Franco Molteni

Director

Villa Beretta Rehabilitation Center

研究点 (1)

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