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Completed

NCT Number: NCT01388738

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

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Institute of Brain

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citicoline

Drug

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

L-Alpha glycerylphosphorylcholine

Drug

choline alfoscerate IV 1000mg daily 10 days

Cerebrolysin

Drug

Cerebrolysin IV 10 ml daily 10 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Clinical Institute of the Brain, Russia

Other

Collaborators

  • Ever Neuro Pharma GmbH
  • Nycomed
  • Veropharm

Registry information

Official study title

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

Acronym: 3C

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 7, 2011
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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