The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)

Launched by FEDERAL STATE BUDGETARY INSTITUTION, V. A. ALMAZOV FEDERAL NORTH-WEST MEDICAL RESEARCH CENTRE, OF THE MINISTRY OF HEALTH · Feb 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how certain factors related to our body’s natural clock (circadian rhythms) can affect recovery after an ischemic stroke, which happens when blood flow to the brain is blocked. Researchers want to find out if combining melatonin, a hormone that helps regulate sleep, with exposure to blue light can improve sleep quality, brain recovery, and overall outcomes for patients who have had a recent stroke. The main idea is that better sleep might help the brain heal more effectively after a stroke.

To participate in this study, individuals need to be between 18 and 80 years old and have experienced a moderate to severe ischemic stroke within the past day. Participants must have consented to join the trial and should not have certain health conditions, such as serious heart issues, severe sleep problems, or any recent strokes. Those who join the trial will receive either the treatment being tested or a placebo (a harmless imitation) and will be monitored for their sleep and recovery progress. This trial is currently recruiting participants, and it aims to explore new ways to enhance recovery after a stroke through better sleep management.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.