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

Stroke Clinical Trial

— 3C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388738
• Other study ID #: CIB-NBS-C
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2011
• Last updated: December 22, 2011
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Clinical Institute of the Brain, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ural State Medical Academy
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• citicoline
citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os
• L-Alpha glycerylphosphorylcholine
choline alfoscerate IV 1000mg daily 10 days
• cerebrolysin
Cerebrolysin IV 10 ml daily 10 days

Locations

Country	Name	City	State
Russian Federation	Clinical Institute of Brain	Ekaterinburg	Sverdlovsk region

Sponsors (4)

Lead Sponsor	Collaborator
Clinical Institute of the Brain, Russia	Ever Neuro Pharma GmbH, Nycomed, Veropharm

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEP(motor evoked potential) parameter: motor threshold		2 months	No
Primary	MEP(motor evoked potential) parameter: latency		2 months	No
Primary	MEP(motor evoked potential) parameter: amplitude		2 months	No
Secondary	Medical Research Council (MRC) Scale for Muscle Strength scores		2 months	No
Secondary	Barthel index		2 months	No
Secondary	Modified Rankin Scale (mRS)		2 months	No
Secondary	Number of Participants with Adverse Events		2 months	Yes
Secondary	Change from Baseline in Alpha waves percentage	EEG parameter	2 months	No
Secondary	Change from Baseline in Beta waves percentage	EEG parameters	2 months	No
Secondary	Change from Baseline in Delta waves percentage	EEG parameter	2 months	No
Secondary	Change from Baseline in Theta waves percentage	EEG parameter	2 months	No
Secondary	Presence of the abnormal epileptiform activity	EEG parameters	2 months	Yes