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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

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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.

Trial registration: NCT02033850 (ClinicalTrials.gov Identifier).

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Acknowledgments

The RehAtt study is funded by Tuscany region and Italian Ministry of Health under Grant Aimed Research Call 2010 (Bando Ricerca Finalizzata 2010), Grant number: RF-2010-2321706, PI: Leonardo Pantoni, ES, RV, and EDR are currently supported by the RehAtt study funds.

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Authors and Affiliations

  1. NEUROFARBA Department, Neuroscience Section, University of Florence, Largo Brambilla 3, 50134, Florence, Italy

    Emilia Salvadori, Anna Poggesi, Raffaella Valenti, Domenico Inzitari & Leonardo Pantoni

  2. Stroke Unit and Neurology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy

    Eleonora Della Rocca

  3. Department of Electrical, Electronic, and Information Engineering ‘Guglielmo Marconi’, University of Bologna, Cesena, Italy

    Stefano Diciotti

  4. ‘Mario Serio’ Department of Clinical and Experimental Biomedical Sciences, University of Florence, Florence, Italy

    Mario Mascalchi

  5. Quantitative and Functional Neuroradiology Research Unit, Meyer Children and Careggi Hospitals, Florence, Italy

    Mario Mascalchi

  6. Institute of Neuroscience, Italian National Research Council, Florence, Italy

    Domenico Inzitari

Authors
  1. Emilia Salvadori
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  2. Anna Poggesi
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  3. Raffaella Valenti
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  4. Eleonora Della Rocca
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  5. Stefano Diciotti
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  6. Mario Mascalchi
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  7. Domenico Inzitari
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  8. Leonardo Pantoni
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Corresponding author

Correspondence to Leonardo Pantoni.

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Conflict of interest

ES, AP, RV, EDR, SD, MM reports no disclosures. DI serves as a member in the Editorial Board of Stroke, and is Associate Editor of Neurological Sciences Journals. He has received grants for research by Bayer Italy, and fees for conferences by Boheringer Italy and Bayer Italy. LP serves on the editorial boards of Acta Neurologica Scandinavica and Cerebrovascular Diseases, and as Vascular Cognitive Impairment Section Editor for Stroke.

Ethical approval

The study is carried in accordance with the 1964 Helsinki Declaration and its later amendments and with the ethical standards of the institutional ethics committee, and was approved by local ethics committee.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Salvadori, E., Poggesi, A., Valenti, R. et al. 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. Neurol Sci 37, 1653–1662 (2016). https://doi.org/10.1007/s10072-016-2649-z

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  • DOI: https://doi.org/10.1007/s10072-016-2649-z

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