Motor Effects of Radio Electric Asymmetric Conveyer in Alzheimer's Disease: Results from a Cross-Over Trial

Article type: Research Article

Authors: Olazarán, Javier^{a; b; *} | González, Belén^a | Osa-Ruiz, Emma^a | Felipe-Ruiz, Silvia^a | Boyano, Inmaculada^d | Fontani, Vania^c | Castagna, Alessandro^c | Mendoza, Carolina^a | Zea, María Ascensión^a | Frades, Belén^a | Rinaldi, Salvatore^c | Martínez-Martín, Pablo^{a; e}

Affiliations: [a] Alzheimer Disease Research Unit, Alzheimer Center Reina Sofía Foundation, CIEN Foundation, Carlos III Institute of Health, Madrid, Spain | [b] Service of Neurology, University Hospital Gregorio Marañón, Madrid, Spain | [c] Department of Neuro Psycho Physical Optimization and Department of Regenerative Medicine, Rinaldi Fontani Institute, Florence, Italy | [d] Service of Geriatrics, Móstoles Hospital, Madrid, Spain | [e] CIBERNED, Spain

Correspondence: [*] Correspondence to: Javier Olazarán, Unidad de Investigación Proyecto Alzheimer, Centro Alzheimer Fundación Reina Sofía, Valderrebollo 5, 28031 Madrid, Spain. Tel.: +34 913852200; Fax: +34 913852118; E-mail: jolazaran@fundacioncien.es.

Abstract: We conducted a randomized, cross-over trial to investigate the feasibility, safety, and motor effects of brain stimulation with radio electric asymmetric conveyer (REAC) technique in patients with Alzheimer's disease (AD). Neuropostural optimization (NPO) and sham protocol were administered to 60 patients from the nursing home and day care units of the Alzheimer Center Reina Sofía Foundation. The mean age was 84.1 (SD 7.9) years and 86.7% of the subjects were female. Motor measures were collected at baseline (T1), immediately (T2), seven (T3), and 11 days (T4) after treatment and, following cross-over, immediately (T5), seven (T6), and 11 (T7) days after treatment. Close safety surveillance was conducted from seven days before T1 to the end of the study (T7), with total study duration of 35 days. Wilcoxon test was utilized in the efficacy analysis, considering T1 and T5 as independent baseline assessments and using a threshold of p < 0.05 (corrected) for statistical significance. The NPO protocol was easily administered and well accepted by the participants. Axial movements improved at T3 and T4 after NPO and at T2 after sham NPO, but no significant effects were observed in axial movements in the second phase of the trial. The effects of NPO in gait performance were not consistent. There were six falls between T2 and T7, but only two of them occurred in patients who had received NPO. In light of safety and feasibility of REAC, a trial with the more intense neuropsycho-physical optimization protocol is warranted.

Keywords: Alzheimer's disease, brain stimulation, gait dysfunction, motor performance, neuro postural optimization, nursing homes, radio electric asymmetric conveyer

DOI: 10.3233/JAD-140417

Journal: Journal of Alzheimer's Disease, vol. 42, no. 1, pp. 325-332, 2014