Frontiers in Aging Neuroscience (Nov 2018)
Neurostimulation Combined With Cognitive Intervention in Alzheimer’s Disease (NeuroAD): Study Protocol of Double-Blind, Randomized, Factorial Clinical Trial
- Suellen Marinho Andrade,
- Eliane Araújo de Oliveira,
- Nelson Torro Alves,
- Nelson Torro Alves,
- Ana Cristina Gomes dos Santos,
- Ana Cristina Gomes dos Santos,
- Camila Teresa Ponce Leon de Mendonça,
- Camila Teresa Ponce Leon de Mendonça,
- Danielle Dorand Amorim Sampaio,
- Edyllaine Elidy Querino Cavalcante da Silva,
- Égina Karoline Gonçalves da Fonsêca,
- Égina Karoline Gonçalves da Fonsêca,
- Evelyn Thais de Almeida Rodrigues,
- Evelyn Thais de Almeida Rodrigues,
- Gabriela Nayara Siqueira de Lima,
- Gabriela Nayara Siqueira de Lima,
- Jamerson Carvalho,
- Jamerson Carvalho,
- Jessyca Alves Silvestre da Silva,
- Jessyca Alves Silvestre da Silva,
- Manuella Toledo,
- Manuella Toledo,
- Marine Raquel Diniz da Rosa,
- Marine Raquel Diniz da Rosa,
- Marcia Queiroz de Carvalho Gomes,
- Marcia Queiroz de Carvalho Gomes,
- Melquisedek Monteiro de Oliveira,
- Moema Teixeira Maia Lemos,
- Nágylla Gomes Lima,
- Penha Inácio,
- Penha Inácio,
- Petra Maria da Cruz Ribeiro e Rodrigues,
- Rayssa Gabriela Dantas Ferreira,
- Rayssa Gabriela Dantas Ferreira,
- Renata Cavalcante,
- Renata Cavalcante,
- Renata Emanuela Lyra de Brito Aranha,
- Regina Neves,
- Regina Neves,
- Rodrigo Marmo da Costa e Souza,
- Rodrigo Marmo da Costa e Souza,
- Thainá Magalhães Portugal,
- Wanessa Kallyne Nascimento Martins,
- Vivian Pontes,
- Thiago Monteiro de Paiva Fernandes,
- Thiago Monteiro de Paiva Fernandes,
- Israel Contador,
- Israel Contador,
- Bernardino Fernández-Calvo,
- Bernardino Fernández-Calvo
Affiliations
- Suellen Marinho Andrade
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Eliane Araújo de Oliveira
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Nelson Torro Alves
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Nelson Torro Alves
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- Ana Cristina Gomes dos Santos
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Ana Cristina Gomes dos Santos
- Department of Occupational Therapy, The Federal University of Paraíba, João Pessoa, Brazil
- Camila Teresa Ponce Leon de Mendonça
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Camila Teresa Ponce Leon de Mendonça
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- Danielle Dorand Amorim Sampaio
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Edyllaine Elidy Querino Cavalcante da Silva
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Égina Karoline Gonçalves da Fonsêca
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Égina Karoline Gonçalves da Fonsêca
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- Evelyn Thais de Almeida Rodrigues
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Evelyn Thais de Almeida Rodrigues
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- Gabriela Nayara Siqueira de Lima
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Gabriela Nayara Siqueira de Lima
- Department of Occupational Therapy, The Federal University of Paraíba, João Pessoa, Brazil
- Jamerson Carvalho
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Jamerson Carvalho
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- Jessyca Alves Silvestre da Silva
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Jessyca Alves Silvestre da Silva
- Department of Occupational Therapy, The Federal University of Paraíba, João Pessoa, Brazil
- Manuella Toledo
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Manuella Toledo
- Department of Internal Medicine, The Federal University of Paraíba, João Pessoa, Brazil
- Marine Raquel Diniz da Rosa
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Marine Raquel Diniz da Rosa
- Department of Speech-Language Pathology and Audiology, The Federal University of Paraíba, João Pessoa, Brazil
- Marcia Queiroz de Carvalho Gomes
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Marcia Queiroz de Carvalho Gomes
- Department of Occupational Therapy, The Federal University of Paraíba, João Pessoa, Brazil
- Melquisedek Monteiro de Oliveira
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Moema Teixeira Maia Lemos
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Nágylla Gomes Lima
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Penha Inácio
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Penha Inácio
- Department of Occupational Therapy, The Federal University of Paraíba, João Pessoa, Brazil
- Petra Maria da Cruz Ribeiro e Rodrigues
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Rayssa Gabriela Dantas Ferreira
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Rayssa Gabriela Dantas Ferreira
- Department of Occupational Therapy, The Federal University of Paraíba, João Pessoa, Brazil
- Renata Cavalcante
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Renata Cavalcante
- Department of Occupational Therapy, The Federal University of Paraíba, João Pessoa, Brazil
- Renata Emanuela Lyra de Brito Aranha
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Regina Neves
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Regina Neves
- Brazilian Alzheimer’s Association, João Pessoa, Brazil
- Rodrigo Marmo da Costa e Souza
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Rodrigo Marmo da Costa e Souza
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- Thainá Magalhães Portugal
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Wanessa Kallyne Nascimento Martins
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Vivian Pontes
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Thiago Monteiro de Paiva Fernandes
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Thiago Monteiro de Paiva Fernandes
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- Israel Contador
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- Israel Contador
- Department of Basic Psychology, Psychobiology and Methodology of Behavioral Science, University of Salamanca, Salamanca, Spain
- Bernardino Fernández-Calvo
- Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil
- Bernardino Fernández-Calvo
- Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil
- DOI
- https://doi.org/10.3389/fnagi.2018.00334
- Journal volume & issue
-
Vol. 10
Abstract
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.Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02772185—May 5, 2016.
Keywords
- clinical trial
- dementia
- neuropsychology
- non-pharmacological approaches
- transcranial direct current stimulation
- neuromodulation