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| Name | Class |
|---|---|
| Nycomed | INDUSTRY |
| Veropharm | INDUSTRY |
| Ever Neuro Pharma GmbH | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cerebrolysin | Active Comparator | IV |
|
| L-Alpha glycerylphosphorylcholine | Active Comparator | IV |
|
| citicoline | Active Comparator | IV and per os |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| citicoline | Drug | citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Research Council (MRC) Scale for Muscle Strength scores | 2 months | |
| Barthel index | 2 months | |
| Modified Rankin Scale (mRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Institute of Brain | Yekaterinburg | Sverdlovsk Oblast | 620102 | Russia |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| D005997 | Glycerylphosphorylcholine |
| C006952 | cerebrolysin |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| L-Alpha glycerylphosphorylcholine | Drug | choline alfoscerate IV 1000mg daily 10 days |
|
| cerebrolysin | Drug | Cerebrolysin IV 10 ml daily 10 days |
|
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D005994 | Glycerophosphates |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D054709 | Lecithins |
| D010713 | Phosphatidylcholines |