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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
citicoline
L-Alpha glycerylphosphorylcholine
cerebrolysin
Sponsored by
Clinical Institute of the Brain, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring Navigation Brain Stimulation (NEXSTIM), cerebroprotective drug effectiveness, acute ischemic stroke

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Institute of Brain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

cerebrolysin

L-Alpha glycerylphosphorylcholine

citicoline

Arm Description

IV

IV

IV and per os

Outcomes

Primary Outcome Measures

MEP(motor evoked potential) parameter: motor threshold
MEP(motor evoked potential) parameter: latency
MEP(motor evoked potential) parameter: amplitude

Secondary Outcome Measures

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

Full Information

First Posted
June 27, 2011
Last Updated
December 22, 2011
Sponsor
Clinical Institute of the Brain, Russia
Collaborators
Nycomed, Veropharm, Ever Neuro Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01388738
Brief Title
Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
Acronym
3C
Official Title
Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Clinical Institute of the Brain, Russia
Collaborators
Nycomed, Veropharm, Ever Neuro Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Navigation Brain Stimulation (NEXSTIM), cerebroprotective drug effectiveness, acute ischemic stroke

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cerebrolysin
Arm Type
Active Comparator
Arm Description
IV
Arm Title
L-Alpha glycerylphosphorylcholine
Arm Type
Active Comparator
Arm Description
IV
Arm Title
citicoline
Arm Type
Active Comparator
Arm Description
IV and per os
Intervention Type
Drug
Intervention Name(s)
citicoline
Intervention Description
citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os
Intervention Type
Drug
Intervention Name(s)
L-Alpha glycerylphosphorylcholine
Intervention Description
choline alfoscerate IV 1000mg daily 10 days
Intervention Type
Drug
Intervention Name(s)
cerebrolysin
Intervention Description
Cerebrolysin IV 10 ml daily 10 days
Primary Outcome Measure Information:
Title
MEP(motor evoked potential) parameter: motor threshold
Time Frame
2 months
Title
MEP(motor evoked potential) parameter: latency
Time Frame
2 months
Title
MEP(motor evoked potential) parameter: amplitude
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Medical Research Council (MRC) Scale for Muscle Strength scores
Time Frame
2 months
Title
Barthel index
Time Frame
2 months
Title
Modified Rankin Scale (mRS)
Time Frame
2 months
Title
Number of Participants with Adverse Events
Time Frame
2 months
Title
Change from Baseline in Alpha waves percentage
Description
EEG parameter
Time Frame
2 months
Title
Change from Baseline in Beta waves percentage
Description
EEG parameters
Time Frame
2 months
Title
Change from Baseline in Delta waves percentage
Description
EEG parameter
Time Frame
2 months
Title
Change from Baseline in Theta waves percentage
Description
EEG parameter
Time Frame
2 months
Title
Presence of the abnormal epileptiform activity
Description
EEG parameters
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinical Institute of Brain
City
Ekaterinburg
State/Province
Sverdlovsk region
ZIP/Postal Code
620102
Country
Russian Federation

12. IPD Sharing Statement

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

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