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About
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.
Full description
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:
All participants will attend 7 Visits of the study (Visits 0, 1-6) at 2 sites respectively:
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.
Enrollment
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Inclusion criteria
Exclusion criteria
Premature withdrowal criteria:
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups, including a placebo group
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Central trial contact
Andrey Avgustovich Belkin, Prof.,MD,PhD; Andrey Marisovich Alasheev, MD, PhD
Data sourced from clinicaltrials.gov
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