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

Who is this study for? Patients with Stroke, Sleep Disorders
Status: Recruiting
Location: See location...
Intervention Type: Device, Combination product, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Almazov National Medical Research Centre
RECRUITING
Saint Petersburg
Contact Information
Primary
Lyudmila Korostovtseva
lyudmila_korosto@mail.ru
+79217873548
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Experimental: Blue light exposure + Melatonin treatment
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
Experimental: Melatonin treatment
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
Experimental: Blue light exposure
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)
Placebo_comparator: Placebo group
The participants will receive placebo light exposure in the morning (lamp turned off) and placebo pill treatment in the evening for 14 days
Related Therapeutic Areas
Sponsors
Leads: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

This content was sourced from clinicaltrials.gov