Abstract

Background

Electroencephalography (EEG)-based brain-computer interfaces (BCIs) allow to modulate the sensorimotor rhythms and are emerging technologies for promoting post-stroke motor function recovery. The Promotoer study aims to assess the short and long-term efficacy of the Promotoer system, an EEG-based BCI assisting motor imagery (MI) practice, in enhancing post-stroke functional hand motor recovery. This paper details the statistical analysis plan of the Promotoer study.

Methods

The Promotoer study is a randomized, controlled, assessor-blinded, single-centre, superiority trial, with two parallel groups and a 1:1 allocation ratio. Subacute stroke patients are randomized to EEG-based BCI-assisted MI training or to MI training alone (i.e. no BCI). An internal pilot study for sample size re-assessment is planned. The primary outcome is the effectiveness of the Upper Extremity Fugl-Meyer Assessment (UE-FMA) score. Secondary outcomes include clinical, functional, and user experience scores assessed at the end of intervention and at follow-up. Neurophysiological assessments are also planned. Effectiveness formulas have been specified, and intention-to-treat and per-protocol populations have been defined. Statistical methods for comparisons of groups and for development of a predictive score of significant improvement are described. Explorative subgroup analyses and methodology to handle missing data are considered.

Discussion

The Promotoer study will provide robust evidence for the short/long-term efficacy of the Promotoer system in subacute stroke patients undergoing a rehabilitation program. Moreover, the development of a predictive score of response will allow transferring of the Promotoer system to optimal clinical practice. By carefully describing the statistical principles and procedures, the statistical analysis plan provides transparency in the analysis of data.

Trial registration

ClinicalTrials.gov NCT04353297. Registered on April 15, 2020.

Details

Title
The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a statistical analysis plan for a randomized controlled trial
Author
Cipriani, Marta 1 ; Pichiorri, Floriana 2 ; Colamarino, Emma 3 ; Toppi, Jlenia 3 ; Tamburella, Federica 2 ; Lorusso, Matteo 2 ; Bigioni, Alessandra 2 ; Morone, Giovanni 2 ; Tomaiuolo, Francesco 4 ; Santoro, Filippo 5 ; Cordella, Daniele 6 ; Molinari, Marco 2 ; Cincotti, Febo 3 ; Mattia, Donatella 2 ; Puopolo, Maria 7   VIAFID ORCID Logo 

1  Istituto Superiore di Sanità, Department of Neuroscience, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856); Sapienza University of Rome, Department of Statistical Sciences, Rome, Italy (GRID:grid.7841.a) 
2  Fondazione Santa Lucia, IRCCS, Rome, Italy (GRID:grid.417778.a) (ISNI:0000 0001 0692 3437) 
3  Fondazione Santa Lucia, IRCCS, Rome, Italy (GRID:grid.417778.a) (ISNI:0000 0001 0692 3437); Control, and Management Engineering “Antonio Ruberti”, Sapienza University of Rome, Department of Computer, Rome, Italy (GRID:grid.7841.a) 
4  University of Messina, Department of Clinical and Experimental Medicine, Messina, Italy (GRID:grid.10438.3e) (ISNI:0000 0001 2178 8421) 
5  Research Coordination and Support Service, Istituto Superiore di Sanità, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856) 
6  Istituto Superiore di Sanità, IT Service, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856) 
7  Istituto Superiore di Sanità, Department of Neuroscience, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856) 
Pages
736
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-023-07773-4
ProQuest document ID
2890582618
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.