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. 2018 Nov 2:10:334.
doi: 10.3389/fnagi.2018.00334. eCollection 2018.

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

Suellen Marinho Andrade  1 , Eliane Araújo de Oliveira  1 , Nelson Torro Alves  1   2 , Ana Cristina Gomes Dos Santos  1   3 , Camila Teresa Ponce Leon de Mendonça  1   2 , Danielle Dorand Amorim Sampaio  1 , Edyllaine Elidy Querino Cavalcante da Silva  1 , Égina Karoline Gonçalves da Fonsêca  1   2 , Evelyn Thais de Almeida Rodrigues  1   2 , Gabriela Nayara Siqueira de Lima  1   3 , Jamerson Carvalho  1   2 , Jessyca Alves Silvestre da Silva  1   3 , Manuella Toledo  1   4 , Marine Raquel Diniz da Rosa  1   5 , Marcia Queiroz de Carvalho Gomes  1   3 , Melquisedek Monteiro de Oliveira  1 , Moema Teixeira Maia Lemos  1 , Nágylla Gomes Lima  1 , Penha Inácio  1   3 , Petra Maria da Cruz Ribeiro E Rodrigues  1 , Rayssa Gabriela Dantas Ferreira  1   3 , Renata Cavalcante  1   3 , Renata Emanuela Lyra de Brito Aranha  1 , Regina Neves  1   6 , Rodrigo Marmo da Costa E Souza  1   2 , Thainá Magalhães Portugal  1 , Wanessa Kallyne Nascimento Martins  1 , Vivian Pontes  1 , Thiago Monteiro de Paiva Fernandes  1   2 , Israel Contador  2   7 , Bernardino Fernández-Calvo  1   2
Affiliations

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

Suellen Marinho Andrade et al. Front Aging Neurosci. .

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; neuromodulation; neuropsychology; non-pharmacological approaches; transcranial direct current stimulation.

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Figures

Figure 1
Figure 1
Montage of transcranial direct current stimulation (tDCS) sessions (Left Hemisphere). (A) F3—Dorsolateral prefrontal Cortex; (B) F5—Broca’s area; (C) CP5—Wernicke’s area; (D) P3—Somatosensory association cortex. Electrode position nomenclature of 10/20 System (Electroencephalography).
Figure 2
Figure 2
Flowchart of phases I (double-blind factorial clinical trial), II (crossover) and III (follow-up) of the Neurostimulation combined with Cognitive Intervention in Alzheimer’s disease (AD) Study (NeuroAD). T0: Baseline, pre-intervention measurement. T1–T8: intervention, tDCS and cognitive treatment. T9: endpoint, post-intervention measurement.
See this image and copyright information in PMC

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