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

NCT ID: NCT01388738

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Stroke

Keywords

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Navigation Brain Stimulation (NEXSTIM) cerebroprotective drug effectiveness acute ischemic stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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cerebrolysin

IV

Group Type ACTIVE_COMPARATOR

cerebrolysin

Intervention Type DRUG

Cerebrolysin IV 10 ml daily 10 days

L-Alpha glycerylphosphorylcholine

IV

Group Type ACTIVE_COMPARATOR

L-Alpha glycerylphosphorylcholine

Intervention Type DRUG

choline alfoscerate IV 1000mg daily 10 days

citicoline

IV and per os

Group Type ACTIVE_COMPARATOR

citicoline

Intervention Type DRUG

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

Interventions

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citicoline

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

Intervention Type DRUG

L-Alpha glycerylphosphorylcholine

choline alfoscerate IV 1000mg daily 10 days

Intervention Type DRUG

cerebrolysin

Cerebrolysin IV 10 ml daily 10 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nycomed

INDUSTRY

Sponsor Role collaborator

Veropharm

INDUSTRY

Sponsor Role collaborator

Ever Neuro Pharma GmbH

INDUSTRY

Sponsor Role collaborator

Clinical Institute of the Brain, Russia

OTHER

Sponsor Role lead

Responsible Party

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Clinical Institute of the Brain, Russia

Locations

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Clinical Institute of Brain

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status

Countries

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Russia

Other Identifiers

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CIB-NBS-C

Identifier Type: -

Identifier Source: org_study_id