Investigating how circadian factors affect recovery from ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the impact of circadian factors on neuroplasticity and recovery in patients who have experienced an ischemic stroke. It involves a prospective, interventional, randomized placebo-controlled design with approximately 80 acute stroke patients. Participants will be assigned to one of four groups receiving either blue light exposure combined with melatonin, melatonin alone, blue light alone, or a placebo. The study will assess various parameters including sleep characteristics, molecular circadian biomarkers, and stroke outcomes over a three-month follow-up period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Almazov National Medical Research Centre
  Saint Petersburg, Russia Recruiting

Study contacts

• Principal investigator: Lyudmila Korostovtseva — Almazov National Medical Research Centre
• Study coordinator: Lyudmila Korostovtseva
• Email: lyudmila_korosto@mail.ru
• Phone: +79217873548

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.