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to assess executive network using resting-state fMRI and patterns of brain activation using task fMRI with a cognitive paradigm, against the background of taking the drug in comparison with placebo in patients with post-COVID asthenic syndrome.
A prospective, randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of therapy using functional MRI of the brain in the setting of neuroprotective therapy for the treatment of patients with chronic fatigue syndrome after COVID-19. The study included 30 patients matched by sex and age with confirmed coronavirus infection. All patients were examined with MFI-20, MoCa, FAS-10 scales, MRI using a Siemens MAGNETOM Prisma 3T scanner before and after a course of therapy with EMHPS-M or placebo (15 patients each) using resting state fMRI and with cognitive paradigm. First group received intramuscularly with the dosage regimen of 5 mL of solution (500 mg of ethyl methyl hydroxypyridine succinate + 500 mg of meldonium) once per day for 10 days. Second group received Placebo in the same way.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fMRI with subsequent injection of active drug (Ethyl methyl hydroxypyridine succinate + Meldonium) | Experimental | Arm 1 (n=15) performed structural and functional MRI and received intramuscularly with the dosage regimen of 5 mL of solution (500 mg of ethyl methyl hydroxypyridine succinate + 500 mg of meldonium) once per day for 10 days |
|
| fMRI with subsequent injection of placebo | Placebo Comparator | Arm 2 (n=15) performed structural and functional MRI and received Placebo in the same way. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structural and functional MRI | Other | MRI using a Siemens MAGNETOM Prisma 3T scanner before and after a course of therapy, using resting state fMRI and with cognitive paradigm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changing patterns of brain activation using task fMRI with a cognitive paradigm | Changing patterns of brain activation using task fMRI with a cognitive paradigm, against the background of taking Brainmax in comparison with placebo in patients with post-COVID asthenic syndrome. | From baseline to Visit 2 (day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Asthenia on a scale Multidimensional Fatigue Inventory (MFI-20) after the completion of the parenteral therapy | MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue. Mean decrease of MFI-20 asthenia scale score after the completion of the parenteral therapy |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications for MRI:
Prohibited drugs/dietary supplements:
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| Name | Affiliation | Role |
|---|---|---|
| Marine Tanashyan, MD, PhD | Federal State Budgetary Research Institution "Research Centre of Neurology" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Research Institution "Research Centre of Neurology" | Moscow | Russia |
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|
| Ethyl methyl hydroxypyridine succinate + Meldonium | Drug | Ethyl methyl hydroxypyridine succinate 100.0 mg/mL, meldonium dihydrate - 100.0 mg/mL (Solution for intravenous and intramuscular administration) |
|
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| Placebo | Drug | Placebo was used in the same way |
|
| From baseline to Visit 2 (day 10) |
| Fatigue on a Fatigue Assessment Scale (FAS-10) scale after the completion of the parenteral therapy | The FAS is a 10-item general fatigue questionnaire to assess fatigue. Five questions reflect physical fatigue and 5 questions (questions 3 and 6-9) mental fatigue. Subsequently, the total FAS score can be calculated by summing the scores on all questions (recoded scores for questions 4 and 10). The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue. Score dynamics by FAS-10 scale after the completion of the parenteral therapy | From baseline to Visit 2 (day 10) |
| Cognitive function on a Montreal Cognitive Assessment (MoCA) scale after the completion of the parenteral therapy | The Montreal Cognitive Assessment (MoCA) is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal. Score dynamics by MoCA scale after the completion of the parenteral therapy | From baseline to Visit 2 (day 10) |
| ID | Term |
|---|---|
| D001247 | Asthenia |
| D000086382 | COVID-19 |
| D060825 | Cognitive Dysfunction |
| D015673 | Fatigue Syndrome, Chronic |
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D005221 | Fatigue |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C050147 | 3-(2,2,2-trimethylhydrazine)propionate |
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