Prospective Randomized Study of the Modulating Effect of MEXIDOL® as an Adjuvant Stimulant of the Cognitive-emotional Component of the Rehabilitation Treatment in Patients With Acute Cerebral Failure

Аssessment of Attentiveness and Performance

时间窗: 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).

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 \[test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome\].

Dynamics of Cognitive Status

时间窗: 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

The Montreal Cognitive Assessment (MoCA test) \[31 point scale: min value 0, max value 30, higher scores mean a better outcome\]

Severity of Depression

时间窗: 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

The Beck Depression Inventory (BDI scale) \[64 point scale: min value 0, max value 63, higher scores mean a worse outcome\]

Reduction in Anxiety

时间窗: 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

The Hospital Anxiety and Depression Scale (HADS) \[22 point scale: min value 0, max value 21, higher scores mean a worse outcome\]

Severity of Post Intensive Care Syndrome

时间窗: 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

The Post Intensive Care Syndrome (PICS) score \[21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome\]

Dynamics of Level of Mobility

时间窗: 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

The Rivermead index \[16 point scale: min value 0, max value 15, higher scores mean a better outcome\]

Dynamics of the Level of Life

时间窗: 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

The Rehabilitation Routing Scale (RRS) \[7 point scale: min value 0, max value 6, higher scores mean a worse outcome\]

Severity and Dynamics of Muscle Strength

时间窗: 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

The Muscle Strength Quantitative Rating (MRC) Scale \[6 point scale: min value 0, max value 5, higher scores mean a better outcome\]

Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points

时间窗: 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.

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. \[Normal values: min 35 сm/sec, max 95 сm/sec\]

Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points

时间窗: 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.

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. \[It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12\]