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

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ClinicalTrials.gov Identifier: NCT01388738
Recruitment Status : Completed
First Posted : July 7, 2011
Last Update Posted : December 23, 2011
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Stroke Drug: citicoline Drug: L-Alpha glycerylphosphorylcholine Drug: cerebrolysin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
Study Start Date : January 2011
Primary Completion Date : October 2011
Study Completion Date : November 2011
Arms and Interventions

Arm Intervention/treatment
Active Comparator: cerebrolysin
Drug: cerebrolysin
Cerebrolysin IV 10 ml daily 10 days
Active Comparator: L-Alpha glycerylphosphorylcholine
Drug: L-Alpha glycerylphosphorylcholine
choline alfoscerate IV 1000mg daily 10 days
Active Comparator: citicoline
IV and per os
Drug: citicoline
citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os

Outcome Measures

Primary Outcome Measures :
  1. MEP(motor evoked potential) parameter: motor threshold [ Time Frame: 2 months ]
  2. MEP(motor evoked potential) parameter: latency [ Time Frame: 2 months ]
  3. MEP(motor evoked potential) parameter: amplitude [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Medical Research Council (MRC) Scale for Muscle Strength scores [ Time Frame: 2 months ]
  2. Barthel index [ Time Frame: 2 months ]
  3. Modified Rankin Scale (mRS) [ Time Frame: 2 months ]
  4. Number of Participants with Adverse Events [ Time Frame: 2 months ]
  5. Change from Baseline in Alpha waves percentage [ Time Frame: 2 months ]
    EEG parameter

  6. Change from Baseline in Beta waves percentage [ Time Frame: 2 months ]
    EEG parameters

  7. Change from Baseline in Delta waves percentage [ Time Frame: 2 months ]
    EEG parameter

  8. Change from Baseline in Theta waves percentage [ Time Frame: 2 months ]
    EEG parameter

  9. Presence of the abnormal epileptiform activity [ Time Frame: 2 months ]
    EEG parameters

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388738

Russian Federation
Clinical Institute of Brain
Ekaterinburg, Sverdlovsk region, Russian Federation, 620102
Sponsors and Collaborators
Clinical Institute of the Brain, Russia
Ever Neuro Pharma GmbH
More Information

Responsible Party: prof. Andrey A. Belkin, MD, PhD, Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier: NCT01388738     History of Changes
Other Study ID Numbers: CIB-NBS-C
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Keywords provided by Clinical Institute of the Brain, Russia:
Navigation Brain Stimulation (NEXSTIM)
cerebroprotective drug effectiveness
acute ischemic stroke

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cytidine Diphosphate Choline
Neuroprotective Agents
Nootropic Agents
Protective Agents
Physiological Effects of Drugs