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Completed

NCT Number: NCT07758257

Biodiversity and Human Functioning Following Acquired Cerebrovascular Lesions - Phase 2 (EspertaMente)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Villa Beretta Rehabilitation Center

Costa Masnaga, Italy, 23845

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Artificial Light

Device

Patients were exposed to CoeLux for 15 minutes. During light exposure ECG and EEG recordings were performed according to a structured experimental protocol in four successive conditions alternating periods of darkness and light stimulation. The conditions were: PRE-exposure, Exposure, Immediate Post-Exposure (POST1), and Late Post-Exposure Phase (POST2)) designed to characterize both the acute effects of light exposure and the temporal persistence of the induced modifications.

Subjects underwent two points of clinical assessment to investigate cognitive and motor performances before (pre) and after (post) light exposure.

Primary outcomes

  1. Motor Measure

    Time frame: Pre and 10 minutes post light exposure

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

Secondary outcomes

  1. Motor Measure

    Time frame: Pre and 10 minutes post light exposure

    10 metres walking test: 10mWT (lower values better performance)

  2. Motor Measure

    Time frame: Pre and 10 minutes post light exposure

    Box and Blocks Test: BBT ( higher values better performance)

  3. Motor Measure

    Time frame: Pre and 10 minutes post light exposure

    Berg Balance Scale: BBS (0-56 higher values better performance)

  4. Cognitive Measure

    Time frame: Pre and 10 minutes post light exposure

    Go/noGo Test: Go/nGo (0-100 higher values better accuracy)

  5. Cognitive Measure

    Time frame: Pre and 10 minutes post light exposure

    Trail Making Test A-B: TMT_A-B (lower values better performance)

  6. Biomarkers from EEG data

    Time frame: Pre, during 15 minutes of light exposure (EXP), immediately after light exposure (POST1), 10 minutes after light exposure (POST2)

    Power Spectral Density according to frequency band

  7. Biomarkers from ECG

    Time frame: Pre, during 15 minutes of light exposure (EXP), immediately after light exposure (POST1), 10 minutes after light exposure (POST2)

    HRV time and frequency indexes

  8. Biomarkers from blood sample

    Time frame: Pre, after light exposure (POST1), after 10 minutes of light exposure (POST2)

    cortisol, melatonin, catecholamines, genetic polymorphisms,inflammatory cytokines

  9. Biomarkers from saliva sample

    Time frame: Pre, after light exposure (POST1), 10 minutes after light exposure (POST2)

    microRNA

Sponsors and collaborators

Lead sponsor

Dr. Franco Molteni

Other

Collaborators

  • IRCCS Eugenio Medea
  • IRCCS Fondazione Don Carlo Gnocchi ONLUS

Registry information

Official study title

Esposoma: Biodiversità e Human Functioning Post Lesioni Vascolari Cerebrali Acquisite

Acronym: EspertaMente

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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