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.
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.
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 group | Role | What they receive |
|---|---|---|
| Light exposure | Experimental | Patients 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.
Motor Measure
Timed Up and Go Test: TUG (lower values better performance)
Measured: Pre and 10 minutes post light exposure
Secondary outcomes (9)
Motor Measure
10 metres walking test: 10mWT (lower values better performance)
Measured: Pre and 10 minutes post light exposure
Motor Measure
Box and Blocks Test: BBT ( higher values better performance)
Measured: Pre and 10 minutes post light exposure
Motor Measure
Berg Balance Scale: BBS (0-56 higher values better performance)
Measured: Pre and 10 minutes post light exposure
Cognitive Measure
Go/noGo Test: Go/nGo (0-100 higher values better accuracy)
Measured: Pre and 10 minutes post light exposure
Cognitive Measure
Trail Making Test A-B: TMT_A-B (lower values better performance)
Measured: Pre and 10 minutes post light exposure
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)
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)
Biomarkers from blood sample
cortisol, melatonin, catecholamines, genetic polymorphisms,inflammatory cytokines
Measured: Pre, after light exposure (POST1), after 10 minutes of light exposure (POST2)
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.
- First posted11 Aug 2026
- Study start1 Sep 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dr. Franco Molteni
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Eugenio Medea, IRCCS Fondazione Don Carlo Gnocchi ONLUS
- Responsible party
- Sponsor-investigator, Dr. Franco Molteni, Villa Beretta Rehabilitation Center
- Investigators
- Franco Molteni, MD, Study chair, Villa Beretta Rehabilitation Center- Valduce Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esposoma: Biodiversità e Human Functioning Post Lesioni Vascolari Cerebrali Acquisite
- ClinicalTrials.gov ID
- NCT07758257
- Acronym / sponsor ID
- EspertaMente / Espertamente Fase2
- Conditions
- Stroke
- Keywords
- stroke, natural light, HRV, EEG, exposome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Franco MolteniUniversity, hospital or other
- Collaborators
- IRCCS Eugenio Medea, IRCCS Fondazione Don Carlo Gnocchi ONLUS
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light exposure | Experimental | Device: Artificial LightPatients will be exposed to one single session of artificial light simulating the natural light |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial LightPatients 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. | Device | Light exposure |
Primary outcome
Motor Measure
Time frame: Pre and 10 minutes post light exposure
Timed Up and Go Test: TUG (lower values better performance)
9 secondary outcomes
Motor Measure
Time frame: Pre and 10 minutes post light exposure
Motor Measure
Time frame: Pre and 10 minutes post light exposure
Motor Measure
Time frame: Pre and 10 minutes post light exposure
Cognitive Measure
Time frame: Pre and 10 minutes post light exposure
Cognitive Measure
Time frame: Pre and 10 minutes post light exposure
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)
Biomarkers from ECG
Time frame: Pre, during 15 minutes of light exposure (EXP), immediately after light exposure (POST1), 10 minutes after light exposure (POST2)
Biomarkers from blood sample
Time frame: Pre, after light exposure (POST1), after 10 minutes of light exposure (POST2)
Biomarkers from saliva sample
Time frame: Pre, after light exposure (POST1), 10 minutes after light exposure (POST2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Molteni, MD study chair
Villa Beretta Rehabilitation Center- Valduce Hospital
1 site in 1 country: see every site and its status.
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.