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Completed

NCT Number: NCT06221826

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

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

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Key information

Conditions

Ischemic Stroke, Acute Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Ischemic Stroke Nervous System Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brain Institute Clinic

Yekaterinburg, Sverdlovsk Oblast, 623702, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mexidol

Drug

Neurocytoprotector

Other names: Ethylmethylhydroxypyridine Succinate

Primary outcomes

  1. Аssessment of Attentiveness and Performance

    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).

    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].

  2. Dynamics of Cognitive Status

    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

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

  3. Severity of Depression

    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

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

  4. Reduction in Anxiety

    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

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

  5. Severity of Post Intensive Care Syndrome

    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

    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]

  6. Dynamics of Level of Mobility

    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

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

  7. Dynamics of the Level of Life

    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

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

  8. Severity and Dynamics of Muscle Strength

    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

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

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

    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.

    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]

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

    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.

    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 outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pharmasoft

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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