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

Clinical Institute of the Brain, Russia

Status and phase: Completed; Phase 3

Conditions: Stroke

Treatments: Drug: L-Alpha glycerylphosphorylcholine; Drug: cerebrolysin; Drug: citicoline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01388738

CIB-NBS-C

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

cerebrolysin

Active Comparator group

Description:

IV

Treatment:

Drug: cerebrolysin

L-Alpha glycerylphosphorylcholine

Active Comparator group

Description:

IV

Treatment:

Drug: L-Alpha glycerylphosphorylcholine

citicoline

Active Comparator group

Description:

IV and per os

Treatment:

Drug: citicoline