Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.

Study Overview
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Brief Summary
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Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's very important to choose the right way of the management of the patient and an appropriate drugs. There is a large number of the so-called neuroprotective drugs, which were effective in laboratory, but didn't show positive results in clinical studies with using traditional clinical scales scores as a primary outcome measures. Specialists suggest, that the investigators could receive better results if the investigators change design of the studies, particularly if the investigators select more precise and sensitive method of assessment. Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation of the changes in the motor centers and motor tracts after administration of different cerebroprotective drugs. (The substances won't be compared to each other).

Official Title
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Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.

Conditions
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Stroke

Intervention / Treatment
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* Drug: citicoline
* Drug: L-Alpha glycerylphosphorylcholine
* Drug: cerebrolysin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients from 3 to 6 months after ischemic stroke hemispheric infarction paresis from 2 to 4 scores by Medical Research Council Weakness Scale (MRC) Exclusion Criteria: history of seizures pregnancy, lactation cognitive deficiency (poor compliance) acute renal failure acute hepatic failure oncological history cardiac pacemakers and other metal implants regular intake of any nootropic drugs Modified Ashford Scale scores 3 and more regular intake of anticonvulsants, neuromuscular relaxants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cerebrolysin<br>IV | Drug: cerebrolysin<br>* Cerebrolysin IV 10 ml daily 10 days<br>|
| Active Comparator: L-Alpha glycerylphosphorylcholine<br>IV | Drug: L-Alpha glycerylphosphorylcholine<br>* choline alfoscerate IV 1000mg daily 10 days<br>|
| Active Comparator: citicoline<br>IV and per os | Drug: citicoline<br>* citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEP(motor evoked potential) parameter: motor threshold |  | 2 months | 
| MEP(motor evoked potential) parameter: latency |  | 2 months | 
| MEP(motor evoked potential) parameter: amplitude |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Research Council (MRC) Scale for Muscle Strength scores |  | 2 months | 
| Barthel index |  | 2 months | 
| Modified Rankin Scale (mRS) |  | 2 months | 
| Number of Participants with Adverse Events |  | 2 months | 
| Change from Baseline in Alpha waves percentage | EEG parameter | 2 months | 
| Change from Baseline in Beta waves percentage | EEG parameters | 2 months | 
| Change from Baseline in Delta waves percentage | EEG parameter | 2 months | 
| Change from Baseline in Theta waves percentage | EEG parameter | 2 months | 
| Presence of the abnormal epileptiform activity | EEG parameters | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Navigation Brain Stimulation (NEXSTIM), cerebroprotective drug effectiveness, acute ischemic stroke