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

This study has been completed.
Sponsor:
Collaborators:
Nycomed
Veropharm
Ever Neuro Pharma GmbH
Information provided by:
Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier:
NCT01388738
First received: June 27, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Stroke
Drug: citicoline
Drug: L-Alpha glycerylphosphorylcholine
Drug: cerebrolysin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.

Further study details as provided by Clinical Institute of the Brain, Russia:

Primary Outcome Measures:
  • MEP(motor evoked potential) parameter: motor threshold [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • MEP(motor evoked potential) parameter: latency [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • MEP(motor evoked potential) parameter: amplitude [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medical Research Council (MRC) Scale for Muscle Strength scores [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Barthel index [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Modified Rankin Scale (mRS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Alpha waves percentage [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    EEG parameter

  • Change from Baseline in Beta waves percentage [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    EEG parameters

  • Change from Baseline in Delta waves percentage [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    EEG parameter

  • Change from Baseline in Theta waves percentage [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    EEG parameter

  • Presence of the abnormal epileptiform activity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    EEG parameters


Estimated Enrollment: 30
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cerebrolysin
IV
Drug: cerebrolysin
Cerebrolysin IV 10 ml daily 10 days
Active Comparator: L-Alpha glycerylphosphorylcholine
IV
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388738

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

No publications provided

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
Study First Received: June 27, 2011
Last Updated: December 22, 2011
Health Authority: Russia: Ural State Medical Academy

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

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Cerebrolysin
Cytidine Diphosphate Choline
Neuroprotective Agents
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014