NCT05247125 The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
| NCT ID | NCT05247125 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
| Condition | Ischemic Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2022-03-01 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Lyudmila Korostovtseva
PRINCIPAL INVESTIGATOR
Almazov National Medical Research Centre
Frequently Asked Questions
Who can join the NCT05247125 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ischemic Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05247125 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05247125 currently recruiting?
Yes, NCT05247125 is actively recruiting participants. Contact the research team at lyudmila_korosto@mail.ru for enrollment information.
Where is the NCT05247125 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT05247125 clinical trial?
NCT05247125 is sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. The principal investigator is Lyudmila Korostovtseva at Almazov National Medical Research Centre. The trial plans to enroll 80 participants.
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