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The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure
Modern neurorehabilitation is a set of basic and adjuvant treatment methods that provide a modulating effect on the neurorestoration process. The range of basic rehabilitation practices includes kinesiotherapy, occupational therapy, speech therapy, and neuropsychology. Adjuvant methods include physiotherapeutic and medicinal methods. For this study, the investigators chose MEXIDOL® as an adjuvant metabolic medicine, which has the ability to modulate receptor complexes of brain membranes, in particular benzodiazepine, GABA, acetylcholine, enhancing their ability to bind to specific ligands. This pharmacodynamic feature of the drug can have a positive effect on the psycho-emotional state of patients, which in turn will increase motivation and, consequently, the success of the rehabilitation process
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main (Mexidol and standard treatment) | Experimental | Mexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment |
|
| Control | No Intervention | Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mexidol | Drug | Neurocytoprotector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Аssessment of Attentiveness and Performance | Schulte test [work efficiency]. Test methodology: the subject is successively shown 5 tables (5x5), in the cells of which numbers (from 1 to 25) are randomly located. It is required to show and name all the numbers in ascending order (from 1 to 25). The time spent on each table separately is recorded. Depending on the objectives, the excess of the standard (40-50 sec) time spent on each table and the dynamics of time indicators, or the average or total result of the examination for all five tables, are analyzed [test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome]. | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66). |
| Dynamics of Cognitive Status | The Montreal Cognitive Assessment (MoCA test) [31 point scale: min value 0, max value 30, higher scores mean a better outcome] | Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66); Day 66 reported |
| Severity of Depression | The Beck Depression Inventory (BDI scale) [64 point scale: min value 0, max value 63, higher scores mean a worse outcome] | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
| Reduction in Anxiety | The Hospital Anxiety and Depression Scale (HADS) [22 point scale: min value 0, max value 21, higher scores mean a worse outcome] | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
| Severity of Post Intensive Care Syndrome |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Registration of adverse events related to Mexidol and significant differences in vital signs between groups | Throughout the study [From Day 1 up to Day 66] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Institute Clinic | Yekaterinburg | Sverdlovsk Oblast | 623702 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38676685 | Background | Belkin AA, Belkin VA, Vasilchenko IE, Pinchuk EA. [Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency]. Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(4):108-117. doi: 10.17116/jnevro2024124041108. Russian. |
| Label | URL |
|---|---|
| Belkin AA, Belkin VA, Vasilchenko IE, Pinchuk EA. \[Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency\] | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Main (Mexidol and Standard Treatment) | Mexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment Mexidol: Neurocytoprotector |
| FG001 | Control | Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main (Mexidol and Standard Treatment) | Mexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment Mexidol: Neurocytoprotector |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Аssessment of Attentiveness and Performance | Schulte test [work efficiency]. Test methodology: the subject is successively shown 5 tables (5x5), in the cells of which numbers (from 1 to 25) are randomly located. It is required to show and name all the numbers in ascending order (from 1 to 25). The time spent on each table separately is recorded. Depending on the objectives, the excess of the standard (40-50 sec) time spent on each table and the dynamics of time indicators, or the average or total result of the examination for all five tables, are analyzed [test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome]. | Posted | Median | Inter-Quartile Range | seconds | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66). |
|
Throughout the study [From Day 1 up to Day 66]
No adverse events were reported in the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main (Mexidol and Standard Treatment) | Mexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment Mexidol: Neurocytoprotector |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meshcherskiy Y.E., Medical director | Pharmasoft | +7(495)626-47-55 | 140 | meshcherskiy_y@pharmasoft.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2023 | Oct 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C070020 | emoxypine succinate |
| C517040 | ethylmethylhydroxypyridine succinate |
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The Post Intensive Care Syndrome (PICS) score [21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome] |
| Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
| Dynamics of Level of Mobility | The Rivermead index [16 point scale: min value 0, max value 15, higher scores mean a better outcome] | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
| Dynamics of the Level of Life | The Rehabilitation Routing Scale (RRS) [7 point scale: min value 0, max value 6, higher scores mean a worse outcome] | Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
| Severity and Dynamics of Muscle Strength | The Muscle Strength Quantitative Rating (MRC) Scale [6 point scale: min value 0, max value 5, higher scores mean a better outcome] | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
| Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points | Systolic cerebral blood flow velocity (Vs) was measured in сm/sec using transcranial Doppler ultrasonography (TCD). Measurements were taken for each participant at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [Normal values: min 35 сm/sec, max 95 сm/sec] | The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion. |
| Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points | The Overshoot Coefficient (OC) is a ratio reflecting the change in systolic cerebral blood flow velocity before and after specific stimuli. It was calculated based on transcranial Doppler measurements at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12] | The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion. |
Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cognitive status [MoCA] | The Montreal Cognitive Assessment (MoCA test) [31 point scale: min value 0, max value 30, higher scores mean a better outcome] | Mean | Standard Deviation | units on a scale |
|
| The Rehabilitation Routing Scale (RRS) | The Rehabilitation Routing Scale (RRS) [7 point scale: min value 0, max value 6, higher scores mean a worse outcome] | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control | Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days |
|
|
| Primary | Dynamics of Cognitive Status | The Montreal Cognitive Assessment (MoCA test) [31 point scale: min value 0, max value 30, higher scores mean a better outcome] | Posted | Mean | Standard Deviation | score on a scale | Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66); Day 66 reported |
|
|
|
| Primary | Severity of Depression | The Beck Depression Inventory (BDI scale) [64 point scale: min value 0, max value 63, higher scores mean a worse outcome] | Posted | Mean | Standard Deviation | score on a scale | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
|
|
|
| Primary | Reduction in Anxiety | The Hospital Anxiety and Depression Scale (HADS) [22 point scale: min value 0, max value 21, higher scores mean a worse outcome] | Posted | Mean | Standard Deviation | score on a scale | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
|
|
|
| Primary | Severity of Post Intensive Care Syndrome | The Post Intensive Care Syndrome (PICS) score [21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome] | Posted | Mean | Standard Deviation | score on a scale | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
|
|
|
| Primary | Dynamics of Level of Mobility | The Rivermead index [16 point scale: min value 0, max value 15, higher scores mean a better outcome] | Posted | Mean | Standard Deviation | score on a scale | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
|
|
|
| Primary | Dynamics of the Level of Life | The Rehabilitation Routing Scale (RRS) [7 point scale: min value 0, max value 6, higher scores mean a worse outcome] | Posted | Mean | Standard Deviation | score on a scale | Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
|
|
|
| Primary | Severity and Dynamics of Muscle Strength | The Muscle Strength Quantitative Rating (MRC) Scale [6 point scale: min value 0, max value 5, higher scores mean a better outcome] | Posted | Mean | Standard Deviation | score on a scale | Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported |
|
|
|
| Primary | Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points | Systolic cerebral blood flow velocity (Vs) was measured in сm/sec using transcranial Doppler ultrasonography (TCD). Measurements were taken for each participant at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [Normal values: min 35 сm/sec, max 95 сm/sec] | Posted | Mean | Standard Deviation | сm/sec | The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion. |
|
|
|
| Primary | Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points | The Overshoot Coefficient (OC) is a ratio reflecting the change in systolic cerebral blood flow velocity before and after specific stimuli. It was calculated based on transcranial Doppler measurements at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12] | Posted | Mean | Standard Deviation | ratio | The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion. |
|
|
|
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Registration of adverse events related to Mexidol and significant differences in vital signs between groups | Posted | Number | Adverse events | Throughout the study [From Day 1 up to Day 66] |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days | 0 | 30 | 0 | 30 | 0 | 30 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Start of the Schulte test |
|
| End of the Schulte test |
|
| End of the infusion |
|
| Start of the Schulte test |
|
| End of the Schulte test |
|
| End of the infusion |
|