NCT06922409Recruiting
The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation.
The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation
Source: ClinicalTrials.gov · Last updated 15 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Background: Light is the most important regulator of circadian rhythm. Naturalistic light, which contains the spectrum of sunlight throughout the day, has been shown to have a positive impact on mental states such as depression and fatigue in stroke and other diseases requiring long-term hospitalization. Depression and fatigue are very common complications after stroke, with a frequency of 30% and 85%, respectively. Both are significantly related to reduced quality of life and early death. Both the causes and pathophysiology behind these complications are unknown, but it is assumed that disturbances (inflammation and cell death) in brain areas and brain networks related to arousal, sleep, circadian rhythm, and the frontal lobe play a role. The hypothesis is that it is possible to detect changes in brain networks related to depression and fatigue by MRI, and that naturalistic light will affect these changes. Method: Stroke patients requiring a minimum of 10 days of rehabilitation are transferred to a neurorehabilitation unit with naturalistic lighting. Examination: Validated tests for fatigue, depression, sleep and cognitive functions. Pathophysiological studies: * MRI focusing on cerebral blood flow, metabolism, and cerebral networks. * Spinal fluid analyses for hormones and markers involved in immunological response as well as wakefulness/arousal and depression. * Sleep assessments.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 10 Apr 2025
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Stroke
- NCT number
- NCT06922409
What you commit to
- Study type: Interventional
- Planned participants: 45
- From 10 Apr 2025 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- GCS \< 15
- No functioning nervus opticus or retina in both eyes
- Unable to open both eyes
- Non communicating patients e.g. severe aphasia (incompetent patients)
- Unable to cooperate to the physical examinations
- Less than 10 days of hospitalization in the rehabilitation department
- Claustrophobia
- If the sub investigator finds the study participant unfit to conduct the investigations
Who the study is looking for
- Patients scoring moderate-severe fatigue and/or depression OR NO fatigue and/or depressione which are evaluated as candidates for the rehabilitation unit.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Health and Medical Sciences - University of Copenhagen Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.