Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke. "3C"

Completed

Phase 3 Results N/A

Trial Description

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).

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors