Trial | NCT01388738  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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).
Study Started
Jan 31
2011
Primary Completion
Oct 31
2011
Study Completion
Nov 30
2011
Last Update
Dec 23
2011
Estimate

Drug citicoline

citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os

Drug L-Alpha glycerylphosphorylcholine

choline alfoscerate IV 1000mg daily 10 days

Drug cerebrolysin

Cerebrolysin IV 10 ml daily 10 days

cerebrolysin Active Comparator

IV

L-Alpha glycerylphosphorylcholine Active Comparator

IV

citicoline Active Comparator

IV and per os

Criteria 

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
No Results Posted