PHARMACOLOGICAL NEUROMODULATION IN COMPLEX REPARATIVE THERAPY OF ISCHEMIC STROKE: “COMPLEX REPAIR IN ISHEMIC STROKE-ARM” TRIAL
A.A. Belkin (1, 2), A.M. Alasheev (1), E.V. Prazdnichkova (1), D.G. Pozdnyakov (2), A.I. Sobolev (2)
1) Sverdlovsk Regional Clinical Hospital № 1, Yekaterinburg, Russia;
2) OOO “Clinic of the Brain Institute”, Berezovsky, Sverdlovsk Region, Russia
Background. In a pilot study using the method of navigated brain stimulation (NBS), the effect of Cerebrolysin on the motor center of paralytic limbs in the form of changes in the neuron excitation threshold in the area of interest in response to magnetic stimulation and an increase in the area of the cortex responsive to stimulation were found. These facts became the basis for planning a new study using Cerebrolysin as a potential modulator of neurorestoration. Objective. Evaluation of the effect of Cerebrolysin® in combination with standard therapy on the dynamics of paresis of the upper limb in patients with acute ischemic stroke in the middle cerebral artery territory. Methods. A randomized, double-blind, placebo-controlled study of the efficacy and safety of Cerebrolysin® in acute ischemic stroke. It is planned to enroll 30 patients in study: 15 in the treatment group and 15 in the control groups. Patients are randomized to one of the groups: standard therapy in combination with the use of Cerebrolysin infusions, or standard therapy in combination with the use of placebo infusions according to the per-protocol scheme. The scheme provides two courses of therapy: Cerebrolysin 50 ml diluted in saline 50 ml, one infusion of Cerebrolysin/placebo (saline 100 ml) per day for 10 days, then a 7-day gap, then a second course of daily Cerebrolysin/placebo infusions for 10 days. Each patient participates in the study for 176–190 days. Primary end point: the dynamics of the hand function according to the results of the Frenchay Arm Test. Conclusion. The study design opens up a new direction in the evaluation of the modulating properties of pharmacological agents in the structure of therapy for acute cerebral insufficiency from onset to late recovery period.
About the Autors
Corresponding author: A.A. Belkin – MD, Prof., Director of OOO «Clinic of the Brain Institute», Berezovsky, Sverdlovsk Region, Russia;
tel. 8 (343) 253-01-00, e-mail: firstname.lastname@example.org, ORCID: https://orcid.org/0000-0002-0544-1492