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

Esposoma: Biodiversità e Human Functioning Post Lesioni Vascolari Cerebrali Acquisite

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07758257
Acronym
EspertaMente
Enrollment
30
Registered
2026-08-11
Start date
2025-09-01
Completion date
2025-10-15
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, natural light, HRV, EEG, exposome

Brief summary

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.

Detailed description

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.

Interventions

DEVICEArtificial Light

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.

Sponsors

Dr. Franco Molteni
Lead SponsorOTHER
IRCCS Eugenio Medea
CollaboratorOTHER
IRCCS Fondazione Don Carlo Gnocchi ONLUS
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Motor MeasurePre and 10 minutes post light exposureTimed Up and Go Test: TUG (lower values better performance)

Secondary

MeasureTime frameDescription
Motor MeasurePre and 10 minutes post light exposure10 metres walking test: 10mWT (lower values better performance)
Cognitive MeasurePre and 10 minutes post light exposureGo/noGo Test: Go/nGo (0-100 higher values better accuracy)
Biomarkers from EEG dataPre, during 15 minutes of light exposure (EXP), immediately after light exposure (POST1), 10 minutes after light exposure (POST2)Power Spectral Density (PSD) according to frequency band
Biomarkers from ECGPre, during 15 minutes of light exposure (EXP), immediately after light exposure (POST1), 10 minutes after light exposure (POST2)HRV time and frequency indexes
Biomarkers from blood samplePre, after light exposure (POST1), after 10 minutes of light exposure (POST2)cortisol, melatonin, catecholamines, genetic polymorphisms,inflammatory cytokines
Biomarkers from saliva samplePre, after light exposure (POST1), 10 minutes after light exposure (POST2)microRNA

Countries

Italy

Contacts

STUDY_CHAIRFranco Molteni, MD

Villa Beretta Rehabilitation Center- Valduce Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026