There is a lack of complex studies which could establish the association between genetic circadian factors with the features and short-term outcomes of ischemic stroke, as well as the effects of various auxiliary therapies for circadian rhythm modulation for neuroplasticity enhancement and improvement of short-term outcomes in ischemic stroke.
The main research hypothesis is that circadian factors influence the recovery from ischemic stroke via sleep-mediated regulation of synaptic plasticity.
The project aims at the investigation of the influence of combined melatonin therapy and blue light exposure on molecular circadian biomarkers, sleep characteristics, neuroplasticity markers and stroke outcome in acute stroke patients.
This study is a prospective, interventional, randomized placebo-controlled trial.
acute (symptom onset to admission <1 days) ischemic stroke
ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery
age 18-80 years
moderate or severe stroke (National Institutes of Health Stroke Scale, NIHSS>=5)
secondary parenchymal hemorrhage (>hemorrhage index (HI)-2)
clinically unstable or life-threatening conditions
previous stroke in the last 6 months
known progressive neurological diseases
Parallel
Blue light exposure + Melatonin treatment
Combination product3 mg Melatonin pill will be given 1 hour before going to bed. Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.
Melatonin treatment
Drug3 mg Melatonin pill will be given 1 hour before going to bed.
Blue light exposure
DeviceBlue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.
Placebo
Combination productPlacebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening
Change in the value of National Institutes of Health Stroke Scale from baseline to 14 days after inclusion
National Institutes of Health Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke, 0-42 scores, higher scores characterize worse impairment
Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14 days after treatment initiation
values of modified Rankin scale (scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke, from 0 (no symptoms) to 6 (dead) points)
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14 days after treatment initiation
Rivermead Mobility Index (a standardized scale used to assess mobility in patients with neurological deficits, a maximum of 15 points is possible; higher scores indicate better mobility performance)
Stroke-related disability assessed by the change in Barthel Index from baseline to 14 days after treatment initiation
Barthel Index (a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance)
Change in Psychomotor vigilance task (mean reaction time) from baseline to 14 days after treatment initiation
The psychomotor vigilance task is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus, the outcome (mean reaction time) is measured in msec
Change in Psychomotor vigilance task (mean reaction time) from baseline to 90 days after inclusion
The psychomotor vigilance task is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus, the outcome (mean reaction time) is measured in msec
Change in Kraepelin test from baseline to 14 days after treatment initiation
Kraepelin test is the test in which the examinee performs a simple single-digit addition. The outcome is the number of correct and incorrect addition operations per each 30 sec and during the whole task, performance index (number of correct addition operations during second part of task / number of correct addition operations during first part of task)
Change in Kraepelin test from baseline to 90 days after inclusion
Kraepelin test is the test in which the examinee performs a simple single-digit addition. The outcome is the number of correct and incorrect addition operations per each 30 sec and during the whole task, performance index (number of correct addition operations during second part of task / number of correct addition operations during first part of task)
Change from baseline in time in bed assessed by actigraphy
time in bed (minutes)
Change from baseline in total sleep time assessed by actigraphy
total sleep time (minutes)
Change from baseline in sleep efficiency assessed by actigraphy
sleep efficiency (%)
Change from baseline in sleep onset latency assessed by actigraphy
sleep onset latency (min)
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