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SAFETY AND EFFICACY OF THE NEUROFEEDBACK COURSE ON A PROTOCOL OF STRENGTHENING OF THE SPECTRAL POWER OF THE ALPHA RHYTHM IN TOP-CLASS ATHLETES

B. A. POLYAEV (1), S. I. EREMEEV (2), O. V. EREMEEVА (3), V. S. KORMILETS (4) 1 -PIROGOV RUSSIAN NATIONAL RESEARCH MEDICAL UNIVERSITY, MOSCOW, RUSSIA 2 -UGORSKY STATE UNIVERSITY, KHANTY-MANSIYSK, RUSSIA 3 -KHANTY-MANSIYSK STATE MEDICAL ACADEMY, KHANTY-MANSIYSK, RUSSIA 4 -CLINICAL MEDICAL AND SURGICAL CENTER OF THE MINISTRY OF HEALTH OF OMSK REGION, OMSK, RUSSIA
The placebo controlled safety study and the study of the efficacy of the prophylactic application of a neurofeedback protocol of the alpha rhythm spectrum power enhancement in the C3A1 monopolar lead in the athletes of high qualification was done. Design of the survey was prospective randomized monocentric single-blind comparative placebo-controlled study. The study included 134 athletes of high qualification. By the methodof randomization 122 participants were included in the neurofeedback group and 12 participants were included in the placebo group. Neurofeedback intervention was based on Peniston protocol. The endpoints of the safety assessment were early termination of participation in the study due to adverse events, and the frequency of development and type of adverse events.The combined primary endpoint of the efficacy estimation was the sum of number of cases of sport results positive dynamic and number of cases without sport results dynamic.It is shown that the neurofeedback course of the alpha rhythm spectrum power enhancement in the C3A1 monopolar lead in the athletes of high qualification was not accompanied by adverse events, which prompted the participants to early terminate their participation in the study. Safety assessment by the type and frequency of adverse reactions showed that in the neurofeedback group and the placebo group, there were cases of arterial hypotonia and complaints of headache. Differences in the frequency of arterial hypotonia before and after exposure in both groups were not found (Χ2A/D = 0.13, p=0.7194; Χ2B/C = 0.00, p=1.0000). There was a rise in the frequency of complaints of headache after placebo intervention (Χ2A/D = 17.78, p<0.001; Χ2B/C = 0.13, p=0.7194).Obtained data about greater efficiency of neurofeedback course compared with placebo. Found a significant change in frequency of the combined primary endpoint (Χ2A/D = 79.04, p<0.001; Χ2B/C = 69.48, p<0.001).
Keywords: 
safety, efficacy, neurofeedback, alpha rhythm, athletes, placebo controlled study.