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

NCT07758257 | Completed

• 1 other identifier: Espertamente Fase2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; natural light; HRV; EEG; exposome

Outcome Measures

Primary Outcomes (1)

• Motor Measure

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

  Pre and 10 minutes post light exposure

Secondary Outcomes (9)

• Motor Measure

  Pre and 10 minutes post light exposure

• Motor Measure

  Pre and 10 minutes post light exposure

• Motor Measure

  Pre and 10 minutes post light exposure

• Cognitive Measure

  Pre and 10 minutes post light exposure

• Cognitive Measure

  Pre and 10 minutes post light exposure

Study Arms (1)

Light exposure

EXPERIMENTAL

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

Device: Artificial Light

Interventions

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.

Light exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Franco Molteni: lead
• IRCCS Eugenio Medea: collaborator
• IRCCS Fondazione Don Carlo Gnocchi ONLUS: collaborator

Study Sites (1)

Villa Beretta Rehabilitation Center

Costa Masnaga, Italy, 23845, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Franco Molteni, MD

  Villa Beretta Rehabilitation Center- Valduce Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: September 1, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)