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

Short name 3C

NCTNCT01388738Other idCIB-NBS-C

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 30 participants (estimated)
Sponsor: Clinical Institute of the Brain, Russia · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Russia
Start: Jan 2011
Primary completion: Oct 2011
Completion: Nov 2011
First posted: 7 Jul 2011 (estimated)
Last update posted: 23 Dec 2011 (estimated)
Conditions: Stroke

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20112012

Ph 3
3C
NCT01388738
Jan 2011 to Nov 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

citicolineDrug
L-Alpha glycerylphosphorylcholineDrug
cerebrolysinDrug

Arms3

Active comparator
cerebrolysin
IV
Active comparator
L-Alpha glycerylphosphorylcholine
IV
Active comparator
citicoline
IV and per os

Primary outcomes3

Outcomes the sponsor listed as primary.

MEP(motor evoked potential) parameter: motor threshold
Time frame · 2 months
MEP(motor evoked potential) parameter: latency
Time frame · 2 months
MEP(motor evoked potential) parameter: amplitude
Time frame · 2 months

Secondary outcomes(9)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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