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

Phase 3

Completed

• Conditions: Stroke
• Interventions: Drug: L-Alpha glycerylphosphorylcholine; Drug: cerebrolysin; Drug: citicoline

• Registration Number: NCT01388738
• Lead Sponsor: Clinical Institute of the Brain, Russia

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-07
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-22
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Alpha glycerylphosphorylcholine	L-Alpha glycerylphosphorylcholine	IV
cerebrolysin	cerebrolysin	IV
citicoline	citicoline	IV and per os

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Barthel index	2 months
Modified Rankin Scale (mRS)	2 months
Medical Research Council (MRC) Scale for Muscle Strength scores	2 months
Number of Participants with Adverse Events	2 months
Change from Baseline in Alpha waves percentage	2 months	EEG parameter
Change from Baseline in Beta waves percentage	2 months	EEG parameters
Change from Baseline in Delta waves percentage	2 months	EEG parameter
Change from Baseline in Theta waves percentage	2 months	EEG parameter
Presence of the abnormal epileptiform activity	2 months	EEG parameters

Trial Locations

Locations (1)

Clinical Institute of Brain; 🇷🇺 Ekaterinburg, Sverdlovsk region, Russian Federation