NCT01388738

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 stroke

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

June 27, 2011

Last Update Submit

December 22, 2011

Conditions

Stroke

Keywords

Navigation Brain Stimulation (NEXSTIM)cerebroprotective drug effectivenessacute ischemic stroke

Outcome Measures

Primary Outcomes (3)

  • MEP(motor evoked potential) parameter: motor threshold

    2 months

  • MEP(motor evoked potential) parameter: latency

    2 months

  • MEP(motor evoked potential) parameter: amplitude

    2 months

Secondary Outcomes (9)

  • Medical Research Council (MRC) Scale for Muscle Strength scores

    2 months

  • Barthel index

    2 months

  • Modified Rankin Scale (mRS)

    2 months

  • Number of Participants with Adverse Events

    2 months

  • Change from Baseline in Alpha waves percentage

    2 months

  • +4 more secondary outcomes

Study Arms (3)

cerebrolysin

ACTIVE COMPARATOR

IV

Drug: cerebrolysin

L-Alpha glycerylphosphorylcholine

ACTIVE COMPARATOR

IV

Drug: L-Alpha glycerylphosphorylcholine

citicoline

ACTIVE COMPARATOR

IV and per os

Drug: citicoline

Interventions

citicolineDRUG

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

citicoline
L-Alpha glycerylphosphorylcholineDRUG

choline alfoscerate IV 1000mg daily 10 days

L-Alpha glycerylphosphorylcholine
cerebrolysinDRUG

Cerebrolysin IV 10 ml daily 10 days

cerebrolysin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients from 3 to 6 months after ischemic stroke
  • hemispheric infarction
  • paresis from 2 to 4 scores by Medical Research Council Weakness Scale (MRC)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Institute of Brain

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Cytidine Diphosphate CholineGlycerylphosphorylcholinecerebrolysin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCytidine DiphosphateCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesGlycerophosphatesTriose Sugar AlcoholsSugar AlcoholsAlcoholsCarbohydratesGlycerophospholipidsPhosphatidic AcidsPhospholipidsMembrane LipidsLipidsLecithinsPhosphatidylcholines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2011

First Posted

July 7, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations

RU(1)