The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin in combination with standard therapy on the dynamics of recovery of the paretic upper limb in patients with acute ischemic stroke.
Each patient participates in the study for 176-190 days (approximately 6 months). The estimated duration of the study is 2 years.
Rehabilitation programs and drug therapy in a stroke aimed, primarily, to the stimulation of the processes of neuroplasticity.
After the screening procedures the eligible patients get randomized in 1 of the 2 groups: either the group of a standard therapy in combination with Cerebrolysin infusions, or the group of a standard therapy in combination with placebo infusions.
The therapy consists of the 3 consecutive periods:
1. st - 10 days of daily infusions of Cerebrolysin / placebo;
2. nd - 7 days break;
3. d - 10 days of daily infusions of Cerebrolysin / placebo.
All participants will attend 7 Visits of the study (Visits 0, 1-6) at 2 sites respectively:
1. st - clinical center #1 - Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg
2. nd - clinical center #2 - Clinical Institute of Brain, Ekaterinburg.
Patients will be transferred from the 1st site to the 2nd one at the moment of time between Visit 2 and Visit 3.
Patients will undergo traditional laboratory and clinical examination procedures and several specific ones such as scale NIHSS, modified Rankin scale, Barthel index, hand Frenchy assessments. All hand Frenchy assessments will be videotaped for later evaluation by an authorized researcher.
All participants will undergo the procedure of navigational transcranial magnetic stimulation of the brain NBS eXimia Nexstim with the use of an individual 3D brain model created on the Visit 0 MRI results basis.
Neither the patient nor the doctor will know whether they receive an investigational drug or placebo.
- Cerebrolysin infusion Drug
Other Names: Cerebrolysin Intervention Desc: Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval ARM 1: Kind: Experimental Label: Cerebrolysin infusion Description: Cerebrolysin, solution for injection, 10 ml vials. Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval
- Placebo infusion Other
Other Names: sodium chloride Intervention Desc: Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval ARM 1: Kind: Experimental Label: Placebo infusion Description: Sodium chloride 0.9%, solution for infusion, 100 ml. Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval.
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Overall dynamics of the hand function assessed by the Frenchay Arm Test||6 months||No|
|Secondary||Dynamics of the hand function assessed by the Frenchay Arm Test||6 months||No|
|Secondary||Dynamics of the grades on the NIHSS scale||6 months||No|
|Secondary||Dynamics of the grades on the modified Rankin scale||6 months||No|
|Secondary||Dynamics of the Barthel index changes||6 months||No|
|Secondary||Dynamics of the cerebral infarction volume decrease according the 3D MRI data||6 months||No|
|Secondary||Dynamics of the hemispheres cortex topology of palms motor centers according to navigated transcranial stimulation of the brain (NBS)||6 months||No|
|Secondary||Dynamics of motor response threshold based on the results of navigated transcranial stimulation of the brain (NBS)||6 months||No|
|Secondary||Dynamics of the amplitude of motor responses||6 months||No|
|Secondary||Dynamics of the latency of motor responses||6 months||No|
|Secondary||Frequency, nature and severity of adverse events.||6 months||Yes|