The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Fatigue and depression
研究概览
简要总结
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.
详细描述
OBJECTIVE AND PURPOSE
To investigate the effect of naturalistic lighting (i.e., artificial light imitating the sunlight rhythm and spectrum) on depression, sleep, executive cognition, and fatigue in a hospital setting among patients admitted for post-stroke rehabilitation. The effect is planned to be measured by questionnaires, MRI modalities, and CSV markers for localizing inflammation, levels of hypocretin and sleep. The hypothesis is based on the findings from the previously light trial.
BACKGROUND INFORMATION
Stroke annually affects approximately 12,000 Danes and there are approximately 75,000 stroke survivors with sequelae after stroke. Stroke is the major cause of acquired cerebral disability among adults, the second most common cause of dementia and the fourth leading cause of death. An effective rehabilitation program is mandatory for optimal recovery; however, post stroke complications in relation to circadian rhythm disruptions counteracts this.
The circadian rhythm association The circadian response is especially sensitive of short-wavelength blue light because of the blue light-sensitive photopigment Melanopsin in the retina, which communicates with the suprachiasmatic nucleus (SCN) through the retinohypothalamic tract (RHT). As sunlight contains blue light, it is essential to imitate the stimulation during the day to entrain the circadian rhythm. Active, working people are exposed to bright sunlight during the day to regulate their circadian rhythm but in hospitals, rehabilitation patients are often indoors and receive only bright light through the hospital window and disturbing light in night time by normal light bulbs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scoring moderate-severe fatigue and/or depression OR NO fatigue and/or depressione which are evaluated as candidates for the rehabilitation unit.
排除标准
- •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
研究组 & 干预措施
Moderate-severe depression or/and fatigue
Naturalistic Light Intervention
干预措施: Naturalistic Light Intervention (Device)
No measured depression or/and fatigue
Naturalistic Light Intervention
干预措施: Naturalistic Light Intervention (Device)
结局指标
主要结局
Fatigue and depression
时间窗: From admission at the rehabilitation unit to the time of discharge aprox. 10 days.
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.
次要结局
- Cognitive function(From admission to the neurorehabilitation unit to the time of discharge aprox 10 days..)
- Sleep quality(From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..)
- Hypocretin(From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..)
- CFS inflammation(From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days.)
研究者
Anders Sode West
MD, Ph.D. Principal Investigator
Rigshospitalet, Denmark