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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01388738

Acronym

Enrollment

Registered

2011-07-07

Start date

2011-01-31

Completion date

2011-11-30

Last updated

2011-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Navigation Brain Stimulation (NEXSTIM), cerebroprotective drug effectiveness, acute ischemic stroke

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).

Interventions

DRUGciticoline

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

DRUGL-Alpha glycerylphosphorylcholine

choline alfoscerate IV 1000mg daily 10 days

DRUGcerebrolysin

Cerebrolysin IV 10 ml daily 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026