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

Frontiers in Aging Neuroscience

Regina Neves¹  Israel Contador²  Manuella Toledo³  Jessyca Alves Silvestre da Silva⁴  Renata Cavalcante⁴  Ana Cristina Gomes dos Santos⁴  Penha Inácio⁴  Rayssa Gabriela Dantas Ferreira⁴  Gabriela Nayara Siqueira de Lima⁴  Marcia Queiroz de Carvalho Gomes⁴  Vivian Pontes⁵  Danielle Dorand Amorim Sampaio⁵  Petra Maria da Cruz Ribeiro e Rodrigues⁵  Renata Emanuela Lyra de Brito Aranha⁵  Thainá Magalhães Portugal⁵  Wanessa Kallyne Nascimento Martins⁵  Edyllaine Elidy Querino Cavalcante da Silva⁵  Melquisedek Monteiro de Oliveira⁵  Moema Teixeira Maia Lemos⁵  Nágylla Gomes Lima⁵  Eliane Araújo de Oliveira⁵  Suellen Marinho Andrade⁵  Camila Teresa Ponce Leon de Mendonça⁶  Rodrigo Marmo da Costa e Souza⁶  Thiago Monteiro de Paiva Fernandes⁶  Nelson Torro Alves⁶  Jamerson Carvalho⁶  Evelyn Thais de Almeida Rodrigues⁶  Égina Karoline Gonçalves da Fonsêca⁶  Bernardino Fernández-Calvo⁶  Marine Raquel Diniz da Rosa⁷ 

[1] Brazilian Alzheimer’s Association, João Pessoa, Brazil;Department of Basic Psychology, Psychobiology and Methodology of Behavioral Science, University of Salamanca, Salamanca, Spain;Department of Internal Medicine, The Federal University of Paraíba, João Pessoa, Brazil;Department of Occupational Therapy, The Federal University of Paraíba, João Pessoa, Brazil;Department of Physiotherapy, The Federal University of Paraíba, João Pessoa, Brazil;Department of Psychology, The Federal University of Paraíba, João Pessoa, Brazil;Department of Speech-Language Pathology and Audiology, The Federal University of Paraíba, João Pessoa, Brazil;

关键词: clinical trial;    dementia;    neuropsychology;    non-pharmacological approaches;    transcranial direct current stimulation;    neuromodulation;   

DOI  :  10.3389/fnagi.2018.00334

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown