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

NCT05247125 | Recruiting Phase 4

• 1 other identifier: 21-75-10173-1 (interventional)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke, Acute; Sleep Disorders, Circadian Rhythm

Keywords

circadian misalignment; neuroplasticity; melatonin; light therapy; circadian disorder

Outcome Measures

Primary Outcomes (4)

• Change in the value of National Institutes of Health Stroke Scale from baseline to 14 days after inclusion

  National Institutes of Health Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke, 0-42 scores, higher scores characterize worse impairment

  From baseline to 14 days after treatment initiation

• Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14 days after treatment initiation

  values of modified Rankin scale (scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke, from 0 (no symptoms) to 6 (dead) points)

  From baseline to 14 days after treatment initiation

• Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14 days after treatment initiation

  Rivermead Mobility Index (a standardized scale used to assess mobility in patients with neurological deficits, a maximum of 15 points is possible; higher scores indicate better mobility performance)

  From baseline to 14 days after treatment initiation

• Stroke-related disability assessed by the change in Barthel Index from baseline to 14 days after treatment initiation

  Barthel Index (a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance)

  From baseline to 14 days after treatment initiation

Secondary Outcomes (33)

• Change in Psychomotor vigilance task (mean reaction time) from baseline to 14 days after treatment initiation

  From baseline to 14 days after treatment initiation

• Change in Psychomotor vigilance task (mean reaction time) from baseline to 90 days after inclusion

  From baseline to 90±7 days after inclusion

• Change in Kraepelin test from baseline to 14 days after treatment initiation

  From baseline to 14 days after treatment initiation

• Change in Kraepelin test from baseline to 90 days after inclusion

  From baseline to 90±7 days after inclusion

• Change in Trail Making test from baseline to 14 days after treatment initiation

  From baseline to 14 days after treatment initiation

Other Outcomes (26)

• Change from baseline in time in bed assessed by actigraphy

  from baseline to 14 days after treatment initiation

• Change from baseline in total sleep time assessed by actigraphy

  from baseline to 14 days after treatment initiation

• Change from baseline in sleep efficiency assessed by actigraphy

  from baseline to 14 days after treatment initiation

Study Arms (4)

Blue light exposure + Melatonin treatment

EXPERIMENTAL

The participants will receive the combination of blue light exposure according to the protocol described by Killgore et al. (2020) and 3 mg of melatonin 1 hour before going to sleep (approximately at 20:00) (Ramos et al 2020) for 14 days

Combination Product: Blue light exposure + Melatonin treatment

Melatonin treatment

EXPERIMENTAL

The participants will receive 3 mg of melatonin 1 hour before going to sleep (approximately at 20:00) (Ramos et al 2020) and the morning placebo-light exposure according to the protocol described by Killgore et al. (2020) for 14 days

Drug: Melatonin treatment

Blue light exposure

EXPERIMENTAL

The participants will receive the morning blue light exposure according to the protocol described by Killgore et al. (2020) for 14 days and placebo pill 1 hour before going to sleep (approximately at 20:00)

Device: Blue light exposure

Placebo group

PLACEBO COMPARATOR

The participants will receive placebo light exposure in the morning (lamp turned off) and placebo pill treatment in the evening for 14 days

Combination Product: Placebo

Interventions

Blue light exposure + Melatonin treatment COMBINATION_PRODUCT

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.

Blue light exposure + Melatonin treatment

Melatonin treatment DRUG

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

Also known as: Melaxen

Melatonin treatment

Blue light exposure DEVICE

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

Also known as: Lamps Lumie/Vitamin L

Blue light exposure

Placebo COMBINATION_PRODUCT

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

RECRUITING

Related Publications (2)

• Korostovtseva L. Ischemic Stroke and Sleep: The Linking Genetic Factors. Cardiol Ther. 2021 Dec;10(2):349-375. doi: 10.1007/s40119-021-00231-9. Epub 2021 Jun 30.

  PMID: 34191267 BACKGROUND

• Bochkarev MV, Korostovtseva LS, Medvedeva EA, Rotar OP, Sviryaev YV, Zhernakova YV, Shalnova SA, Konradi AO, Chazova IE, Boitsov SA, Shlyakhto EV. [Sleep disorders and stroke: data of the esse-rf study]. Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(4. Vyp. 2):73-80. doi: 10.17116/jnevro201911904273. Russian.

  PMID: 31317919 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Chronobiology Disorders; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Lyudmila Korostovtseva

  Almazov National Medical Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyudmila Korostovtseva

CONTACT

+79217873548; lyudmila_korosto@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher, Department for Hypertension

Model Details: patients will be randomized into 4 parallel groups

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 18, 2022
• Study Start: March 1, 2022
• Primary Completion: January 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)