The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
80 participants
Mar 1, 2022
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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)
- intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable)
- informed consent
Exclusion Criteria17
- secondary parenchymal hemorrhage (\>hemorrhage index (HI)-2)
- clinically unstable or life-threatening conditions
- previous stroke in the last 6 months
- known progressive neurological diseases
- known psychiatric diseases
- concomitant benzodiazepine medication
- drug or alcohol abuse
- pregnancy
- inability to participate in the study
- severe sensory aphasia
- melatonin intake at/before admission
- light therapy use at/before admission
- blindness
- severe sleep-disordered breathing (apnea-hypopnea index \>=30/h)
- contraindications to light therapy (severe retinopathy, epilepsy, porphyria, intake of drugs with photosensitizing effects)
- contraindications to melatonin intake (severe bronchial asthma, severe autoimmune disorders, chronic kidney disease 3b stage and higher, leukosis)
- congestive heart failure with reduced ejection fraction (\<=45%) or New York Heart Association (NYHA) classification III-IV functional class.
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Interventions
3 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.
3 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.
Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening
Locations(1)
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NCT05247125