About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
secondary parenchymal hemorrhage (>hemorrhage index (HI)-2)
clinically unstable or life-threatening conditions
previous stroke in the last 6 months
known progressive neurological diseases
Trial design
Treatments tested in this trial
- Blue light exposure + Melatonin treatment
- Melatonin treatment
- Blue light exposure
- Placebo