MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure

Phase 4

Completed

Conditions: Ischemic Stroke, Acute

Interventions: Drug: Mexidol

Registration Number: NCT06221826

Lead Sponsor: Pharmasoft

Brief Summary: The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure

Detailed Description: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Acute Ischemic Stroke
Montreal Cognitive Assessment (MoCA) test >15; ≤22

Exclusion Criteria

Under 18 years old
Epilepsy
Pregnancy
Acute failure of one or more organ systems
Purulent-inflammatory disease of any localization
Participating in any other clinical trial

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Main (Mexidol and standard treatment)	Mexidol	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

Primary Outcome Measures

Name	Time	Method
Аssessment of Attentiveness and Performance	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	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	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	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	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	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	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	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	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	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. \[It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12\]

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Throughout the study [From Day 1 up to Day 66]	Registration of adverse events related to Mexidol and significant differences in vital signs between groups