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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFederal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

About this trial

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

Qualifiers

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)

Disqualifiers

secondary parenchymal hemorrhage (>hemorrhage index (HI)-2)

clinically unstable or life-threatening conditions

previous stroke in the last 6 months

known progressive neurological diseases

Trial design

Treatments tested in this trial

  • Blue light exposure + Melatonin treatment
  • Melatonin treatment
  • Blue light exposure
  • Placebo

Treatment groups

80 Participants
are divided into 4 treatment groups