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

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.

Conditions

• Ischemic Stroke, Acute
• Sleep Disorders, Circadian Rhythm

Interventions

COMBINATION_PRODUCT

Blue light exposure + Melatonin treatment

3 mg Melatonin pill will be given 1 hour before going to bed. Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.

DRUG

Melatonin treatment

3 mg Melatonin pill will be given 1 hour before going to bed.

DEVICE

Blue light exposure

Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.

COMBINATION_PRODUCT

Placebo

Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening

Sponsors & Collaborators

• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

  lead OTHER

Principal Investigators

• Lyudmila Korostovtseva · Almazov National Medical Research Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2026-01-30

Completion

2026-12-31

Countries

• Russia

Study Locations