Neurostimulation Combined With Cognitive Intervention in Alzheimer's Disease (NeuroAD): Study Protocol of Double-Blind, Randomized, Factorial Clinical Trial

Despite advances in the treatment of Alzheimer's disease (AD), there is currently no prospect of a cure, and evidence shows that multifactorial interventions can benefit patients. A promising therapeutic alternative is the use of transcranial direct current stimulation (tDCS) simultaneously wit...

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Published in:	Frontiers in aging neuroscience Vol. 10; p. 334
Main Authors:	Andrade, Suellen Marinho, de Oliveira, Eliane Araújo, Alves, Nelson Torro, Dos Santos, Ana Cristina Gomes, de Mendonça, Camila Teresa Ponce Leon, Sampaio, Danielle Dorand Amorim, da Silva, Edyllaine Elidy Querino Cavalcante, da Fonsêca, Égina Karoline Gonçalves, de Almeida Rodrigues, Evelyn Thais, de Lima, Gabriela Nayara Siqueira, Carvalho, Jamerson, da Silva, Jessyca Alves Silvestre, Toledo, Manuella, da Rosa, Marine Raquel Diniz, Gomes, Marcia Queiroz de Carvalho, de Oliveira, Melquisedek Monteiro, Lemos, Moema Teixeira Maia, Lima, Nágylla Gomes, Inácio, Penha, da Cruz Ribeiro E Rodrigues, Petra Maria, Ferreira, Rayssa Gabriela Dantas, Cavalcante, Renata, de Brito Aranha, Renata Emanuela Lyra, Neves, Regina, da Costa E Souza, Rodrigo Marmo, Portugal, Thainá Magalhães, Martins, Wanessa Kallyne Nascimento, Pontes, Vivian, de Paiva Fernandes, Thiago Monteiro, Contador, Israel, Fernández-Calvo, Bernardino
Format:	Journal Article
Language:	English
Published:	Switzerland Frontiers Research Foundation 02-11-2018 Frontiers Media S.A
Subjects:	Alzheimer's disease Brain-derived neurotrophic factor clinical trial Clinical trials Cognitive ability Dementia Disease Double-blind studies Electrical stimulation of the brain ESB Memory Neurodegenerative diseases neuromodulation neuropsychology Neuroscience non-pharmacological approaches Patients Physiology Systematic review transcranial direct current stimulation Brazil New York United States > US clinical trial neuromodulation neuropsychology dementia non-pharmacological approaches transcranial direct current stimulation
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Summary:	Despite advances in the treatment of Alzheimer's disease (AD), there is currently no prospect of a cure, and evidence shows that multifactorial interventions can benefit patients. A promising therapeutic alternative is the use of transcranial direct current stimulation (tDCS) simultaneously with cognitive intervention. The combination of these non-pharmacological techniques is apparently a safe and accessible approach. This study protocol aims to compare the efficacy of tDCS and cognitive intervention in a double-blind, randomized and factorial clinical trial. One hundred participants diagnosed with mild-stage AD will be randomized to receive both tDCS and cognitive intervention, tDCS, cognitive intervention, or placebo. The treatment will last 8 weeks, with a 12-month follow-up. The primary outcome will be the improvement of global cognitive functions, evaluated by the AD Assessment Scale, cognitive subscale (ADAS-Cog). The secondary outcomes will include measures of functional, affective, and behavioral components, as well as a neurophysiological marker (Brain-derived neurotrophic factor, BDNF). This study will enable us to assess, both in the short and long term, whether tDCS is more effective than the placebo and to examine the effects of combined therapy (tDCS and cognitive intervention) and isolated treatments (tDCS vs. cognitive intervention) on patients with AD. : www.ClinicalTrials.gov, identifier NCT02772185-May 5, 2016.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Reviewed by: Yury Kropotov, N.P. Bechtereva Institute of the Human Brain (RAS), Russia; Ramesh Kandimalla, Indian Institute of Chemical Technology (CSIR), India; Katie Palmer, IRCCS Fondazione Ospedale San Camillo, Italy Edited by: Rommy Von Bernhardi, Pontificia Universidad Católica de Chile, Chile
ISSN:	1663-4365 1663-4365
DOI:	10.3389/fnagi.2018.00334