The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scoring moderate-severe fatigue and/or depression OR NO fatigue and/or depressione which are evaluated as candidates for the rehabilitation unit.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Naturalistic Light Intervention

    Device

    Naturalistic light as an Intervention A 24-hour naturalistic lighting scheme is implemented in all areas and rooms in the unit at Rigshospitalet Glostrup with a computer-controlled lighting scheme (ChromaViso, Denmark). The naturalistic lighting scheme is constantly running. The lighting imitate the sunlight rhythm following the principles of Lucas et al.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Moderate-severe depression or/and fatigueActive comparator 1 intervention
Group B: No measured depression or/and fatigueActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fatigue and depression

Primary hypothesis: Naturalistic light reduce the major depression inventory questionnaire score and multidimensional fatigue inventory questionnaire score from baseline til discharge. Mood-related network will too show positive changes measured by whole brain resting-state connectivity in post-stroke patients compared with a control group without fatigue and depression.

Time frame
From admission at the rehabilitation unit to the time of discharge aprox. 10 days.

Secondary outcomes

1

Cognitive function

Secondary hypothesis: Naturalistic light improves executive cognitive function and processing speed in test included in the Neuropsychology assessments (Verbal fluency, 1 minute each per test: Category fluency (animals) and lexical fluency (s words and a words), System Digit Modalities Test (SDMT), and Stroop test) and furthermore modifies cognitive related network activation measured by fMRI in post-stroke patients compared with a control group without cognitive impairment.

Time frame
From admission to the neurorehabilitation unit to the time of discharge aprox 10 days..
2

Sleep quality

Secondary hypothesis: Naturalistic light improves sleep quality from baseline to discharge measured by polysomnography and Pittsburgh Sleep Quality Index questionnaire in post-stroke patients compared with a control group without poor sleep quality.

Time frame
From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..
3

Hypocretin

Secondary hypothesis: Naturalistic light increase hypocretin levels from baseline to discharge in post stroke patients with measured fatigue and sleepiness compared to a control group without fatigue and sleepiness.

Time frame
From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..
4

CFS inflammation

Secondary hypothesis: The severity of post stroke fatigue and post stroke depression is associated to the level of markers related to cerebral inflammation based on measured CFS inflammation and naturalistic light will decrease this inflammation compared to a control group without fatigue and depression.

Time frame
From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Chromaviso A/S

Collaborator