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

• Status: Not yet recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Treatments: Melatonin

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.