Investigating how circadian factors affect recovery from ischemic stroke

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

This study is testing if different combinations of blue light and melatonin can help people recover better from an ischemic stroke by looking at their sleep and brain healing over three months.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health (other)
• Locations: 1 site (Saint Petersburg)
• Trial ID: NCT05247125 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have experienced a moderate to severe ischemic stroke within the last day.

Not a fit: Patients with secondary hemorrhagic strokes, severe psychiatric conditions, or those unable to participate due to other health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance recovery outcomes for ischemic stroke patients through improved neuroplasticity and sleep regulation.

How similar studies have performed: While studies on circadian factors and stroke recovery are limited, the approach of using light therapy and melatonin is promising and has shown potential in related areas.

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.

Where this trial is running

Saint Petersburg

• Almazov National Medical Research Centre — Saint Petersburg, Russia (RECRUITING)

Study contacts

• Principal investigator: Lyudmila Korostovtseva — Almazov National Medical Research Centre
• Study coordinator: Lyudmila Korostovtseva

Conditions: Ischemic Stroke, Acute, Sleep Disorders, Circadian Rhythm, circadian misalignment, neuroplasticity, melatonin, light therapy, circadian disorder