Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT05247125

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

Led by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Updated on 2025-08-08

80

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute ischemic stroke with symptom onset to admission less than 1 day
  • Stroke affecting branches of anterior, middle, or posterior cerebral arteries
  • Age between 18 and 80 years
  • Moderate or severe stroke with NIH Stroke Scale score 5 or higher
  • Intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable)
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Secondary parenchymal hemorrhage greater than hemorrhage index 2
  • Clinically unstable or life-threatening conditions
  • Previous stroke within 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 or before admission
  • Use of light therapy at or before admission
  • Blindness
  • Severe sleep-disordered breathing with apnea-hypopnea index 30 or higher per hour
  • Contraindications to light therapy (severe retinopathy, epilepsy, porphyria, photosensitizing drugs)
  • Contraindications to melatonin (severe bronchial asthma, severe autoimmune disorders, chronic kidney disease stage 3b or higher, leukosis)
  • Congestive heart failure with reduced ejection fraction 45% or less or NYHA class III-IV functional status

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Almazov National Medical Research Centre

Saint Petersburg, Russia, 197341

Actively Recruiting

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Research Team

L

Lyudmila Korostovtseva

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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