Clinical trial NCT01388738: Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
Official title: Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: Navigation Brain Stimulation (NEXSTIM)
cerebroprotective drug effectiveness
acute ischemic stroke
Lead sponsor: Clinical Institute of the Brain, Russia
Sponsor class: OTHER
Collaborators: name: Nycomed
name: Veropharm
name: Ever Neuro Pharma GmbH
First posted: 2011-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: MEP(motor evoked potential) parameter: motor threshold
timeFrame: 2 months
measure: MEP(motor evoked potential) parameter: latency
timeFrame: 2 months
measure: MEP(motor evoked potential) parameter: amplitude
timeFrame: 2 months
Secondary outcomes:
measure: Medical Research Council (MRC) Scale for Muscle Strength scores
timeFrame: 2 months
measure: Barthel index
timeFrame: 2 months
measure: Modified Rankin Scale (mRS)
timeFrame: 2 months
measure: Number of Participants with Adverse Events
timeFrame: 2 months
measure: Change from Baseline in Alpha waves percentage
timeFrame: 2 months
measure: Change from Baseline in Beta waves percentage
timeFrame: 2 months
measure: Change from Baseline in Delta waves percentage
timeFrame: 2 months
measure: Change from Baseline in Theta waves percentage
timeFrame: 2 months
measure: Presence of the abnormal epileptiform activity
timeFrame: 2 months
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Clinical Institute of Brain
state: Sverdlovsk region
Study officials:
References: