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StrokeEspertaMenteNCT07758257

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

A study testing Artificial Light in people with Stroke, run by Dr. Franco Molteni at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Artificial Light
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
1 Sep 2025to 15 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Villa Beretta Rehabilitation Center

    Costa Masnaga, Italy, 23845

Other trials in Italy

About this study

Official title: Esposoma: Biodiversità e Human Functioning Post Lesioni Vascolari Cerebrali Acquisite

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.

Read the 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.

Conditions
Stroke
Being tested
Artificial Light
Keywords
stroke, natural light, HRV, EEG, exposome
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial LightDevice

    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.

Study groups in NCT07758257
Study groupRoleWhat they receive
Light exposureExperimentalPatients will be exposed to one single session of artificial light simulating the natural light
Receives: Device: Artificial Light

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motor Measure

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

    Measured: Pre and 10 minutes post light exposure

Secondary outcomes (9)
  1. Motor Measure

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

    Measured: Pre and 10 minutes post light exposure

  2. Motor Measure

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

    Measured: Pre and 10 minutes post light exposure

  3. Motor Measure

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

    Measured: Pre and 10 minutes post light exposure

  4. Cognitive Measure

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

    Measured: Pre and 10 minutes post light exposure

  5. Cognitive Measure

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

    Measured: Pre and 10 minutes post light exposure

  6. Biomarkers from EEG data

    Power Spectral Density (PSD) according to frequency band

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

  7. Biomarkers from ECG

    HRV time and frequency indexes

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

  8. Biomarkers from blood sample

    cortisol, melatonin, catecholamines, genetic polymorphisms,inflammatory cytokines

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

  9. Biomarkers from saliva sample

    microRNA

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start1 Sep 2025
  3. Primary completion15 Oct 2025
  4. Study completion15 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07758257
Sponsor's protocol ID
Espertamente Fase2
Acronym
EspertaMente
Status last verified
Aug 2026
First submitted
5 Aug 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Light in people with Stroke, run by Dr. Franco Molteni at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor Measure (time frame: Pre and 10 minutes post light exposure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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