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

• Sponsor: Clinical Institute of the Brain, Russia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01388738
• Collaborator: Nycomed (Industry), Veropharm (Industry), Ever Neuro Pharma GmbH (Industry)
• Enrollment: 30
• Location: 1
• Arms: 3
• Duration (Months): 10
• Patients Per Site Per Month: 3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: citicoline; Drug: L-Alpha glycerylphosphorylcholine; Drug: cerebrolysin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. MEP(motor evoked potential) parameter: motor threshold [2 months]

2. MEP(motor evoked potential) parameter: latency [2 months]

3. MEP(motor evoked potential) parameter: amplitude [2 months]

Secondary Outcome Measures

1. Medical Research Council (MRC) Scale for Muscle Strength scores [2 months]

2. Barthel index [2 months]

3. Modified Rankin Scale (mRS) [2 months]

4. Number of Participants with Adverse Events [2 months]

5. Change from Baseline in Alpha waves percentage [2 months]

   EEG parameter

6. Change from Baseline in Beta waves percentage [2 months]

   EEG parameters

7. Change from Baseline in Delta waves percentage [2 months]

   EEG parameter

8. Change from Baseline in Theta waves percentage [2 months]

   EEG parameter

9. Presence of the abnormal epileptiform activity [2 months]

   EEG parameters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Institute of Brain	Ekaterinburg	Sverdlovsk region	Russian Federation	620102

Sponsors and Collaborators

• Clinical Institute of the Brain, Russia
• Nycomed
• Veropharm
• Ever Neuro Pharma GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01388738
• Other Study ID Numbers: CIB-NBS-C
• First Posted: Jul 7, 2011
• Last Update Posted: Dec 23, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by , ,: Navigation Brain Stimulation (NEXSTIM); cerebroprotective drug effectiveness; acute ischemic stroke
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebrolysin; Cytidine Diphosphate Choline

Study Results

No Results Posted as of Dec 23, 2011