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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Neurocytoprotector
Brain Institute Clinic
Yekaterinburg, Sverdlovsk Oblast, Russia
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 \[test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome\].
Time frame: 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) \[31 point scale: min value 0, max value 30, higher scores mean a better outcome\]
Time frame: 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) \[64 point scale: min value 0, max value 63, higher scores mean a worse outcome\]
Time frame: 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) \[22 point scale: min value 0, max value 21, higher scores mean a worse outcome\]
Time frame: 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
The Post Intensive Care Syndrome (PICS) score \[21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome\]
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Time frame: 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 \[16 point scale: min value 0, max value 15, higher scores mean a better outcome\]
Time frame: 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) \[7 point scale: min value 0, max value 6, higher scores mean a worse outcome\]
Time frame: 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 \[6 point scale: min value 0, max value 5, higher scores mean a better outcome\]
Time frame: 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. \[Normal values: min 35 сm/sec, max 95 сm/sec\]
Time frame: 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. \[It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12\]
Time frame: 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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Registration of adverse events related to Mexidol and significant differences in vital signs between groups
Time frame: Throughout the study [From Day 1 up to Day 66]