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).
- Citicoline (CerAxon®)Drug
Other Names: CDP-choline Intervention Desc: citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os ARM 1: Kind: Experimental Label: citicoline Description: IV and per os
- Cerebrolysin Drug
Other Names: Ever Pharma, Unterach am Attersee, Austria Intervention Desc: Cerebrolysin IV 10 ml daily 10 days ARM 1: Kind: Experimental Label: cerebrolysin Description: IV
- L-Alpha glycerylphosphorylcholine Drug
Intervention Desc: choline alfoscerate IV 1000mg daily 10 days ARM 1: Kind: Experimental Label: L-Alpha glycerylphosphorylcholine Description: IV
- Allocation: Randomized
- Masking: Open Label
- Purpose: Diagnostic
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||MEP(motor evoked potential) parameter: motor threshold||2 months||No|
|Primary||MEP(motor evoked potential) parameter: latency||2 months||No|
|Primary||MEP(motor evoked potential) parameter: amplitude||2 months||No|
|Secondary||Medical Research Council (MRC) Scale for Muscle Strength scores||2 months||No|
|Secondary||Barthel index||2 months||No|
|Secondary||Modified Rankin Scale (mRS)||2 months||No|
|Secondary||Number of Participants with Adverse Events||2 months||Yes|
|Secondary||Change from Baseline in Alpha waves percentage||2 months||No|
|Secondary||Change from Baseline in Beta waves percentage||2 months||No|
|Secondary||Change from Baseline in Delta waves percentage||2 months||No|
|Secondary||Change from Baseline in Theta waves percentage||2 months||No|
|Secondary||Presence of the abnormal epileptiform activity||2 months||Yes|