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

Navigation Brain Stimulation (NBS) 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).

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Drug: cerebrolysin; Drug: L-Alpha glycerylphosphorylcholine; Drug: citicoline

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Sverdlovsk region
    • Ekaterinburg, Sverdlovsk region, Russian Federation, 620102
      • Clinical Institute of Brain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events		2 months
Medical Research Council (MRC) Scale for Muscle Strength scores		2 months
Barthel index		2 months
Modified Rankin Scale (mRS)		2 months
Change from Baseline in Alpha waves percentage	EEG parameter	2 months
Change from Baseline in Beta waves percentage	EEG parameters	2 months
Change from Baseline in Delta waves percentage	EEG parameter	2 months
Change from Baseline in Theta waves percentage	EEG parameter	2 months
Presence of the abnormal epileptiform activity	EEG parameters	2 months

Collaborators and Investigators

• Sponsor: Clinical Institute of the Brain, Russia
• Collaborators: Ever Neuro Pharma GmbH; Nycomed; Veropharm

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2011
• Last Update Submitted That Met QC Criteria: December 22, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: acute ischemic stroke; Navigation Brain Stimulation (NEXSTIM); cerebroprotective drug effectiveness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Nootropic Agents; Cerebrolysin; Cytidine Diphosphate Choline
• Other Study ID Numbers: CIB-NBS-C