title: The rehabilitation of attention in patients with mild cognitive impairment and brain subcortical vascular changes using the Attention Process Training-II. The RehAtt Study: rationale, design and methodology.
abstract: Cerebral small vessel disease (SVD) may cause attentional and executive cognitive deficits. No drug is currently available to improve cognitive performance or to prevent dementia in SVD patients, and cognitive rehabilitation could be a promising approach. We aimed to investigate: (1) the effectiveness of the Attention Process Training-II program in the rehabilitation of patients with mild cognitive impairment (MCI) and SVD; (2) the impact of the induced cognitive improvement on functionality and quality of life; (3) the effect of training on brain activity at rest and the possibility of a training-induced plasticity effect. The RehAtt study is designed as a 3-year prospective, single-blinded, randomized clinical trial. Inclusion criteria were: (1) MCI defined according to Winblad et al. criteria; (2) evidence of impairment across attention neuropsychological tests; (3) evidence on MRI of moderate/severe white matter hyperintensities. All enrolled patients are evaluated at baseline, and after 6 and 12 months, according to an extensive clinical, functional, MRI and neuropsychological protocol. The baseline RehAtt cohort includes 44 patients (66 % males, mean ± SD age and years of education 75.3 ± 6.8 and 8.3 ± 4.3, respectively). After baseline assessment, patients have been randomly assigned to 'attention training' or 'standard care'. Treatments and follow-up visits at 6 months are completed, while follow-up visits at 12 months are ongoing. This study is the first attempt to reduce attention deficits in patients affected by MCI with SVD. The results of this pilot experience will represent an essential background for designing larger multicenter, prospective, double-blinded, randomized and controlled clinical trials.
  
  
  BACKGROUND
  NCT02033850 (ClinicalTrials.gov Identifier).
authors.affiliation: NEUROFARBA Department, Neuroscience Section, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
authors.forename: Emilia
authors.initials: E
authors.lastname: Salvadori
authors.affiliation: NEUROFARBA Department, Neuroscience Section, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Poggesi
authors.affiliation: NEUROFARBA Department, Neuroscience Section, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Valenti
authors.affiliation: Stroke Unit and Neurology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Della Rocca
authors.affiliation: Department of Electrical, Electronic, and Information Engineering 'Guglielmo Marconi', University of Bologna, Cesena, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Diciotti
authors.affiliation: 'Mario Serio' Department of Clinical and Experimental Biomedical Sciences, University of Florence, Florence, Italy.|Quantitative and Functional Neuroradiology Research Unit, Meyer Children and Careggi Hospitals, Florence, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Mascalchi
authors.affiliation: NEUROFARBA Department, Neuroscience Section, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.|Institute of Neuroscience, Italian National Research Council, Florence, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Inzitari
authors.affiliation: NEUROFARBA Department, Neuroscience Section, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. leonardo.pantoni@unifi.it.
authors.forename: Leonardo
authors.identifier: http://orcid.org/0000-0001-7357-8530
authors.initials: L
authors.lastname: Pantoni
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001289:Attention Deficit Disorder with Hyperactivity / Q000000981:diagnostic imaging / Q000209:etiology* / Q000534:rehabilitation*; D059345:Cerebral Small Vessel Diseases / Q000150:complications* / Q000000981:diagnostic imaging; D003072:Cognition Disorders / Q000150:complications*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D016037:Single-Blind Method; D016896:Treatment Outcome
keywords: Attention training; Cerebrovascular diseases; Cognitive rehabilitation; Mild cognitive impairment; Small vessel disease; Vascular dementia