1. The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a study protocol for a randomized controlled trial to test early and long-term efficacy and to identify determinants of response
- Author
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Mattia, D., Pichiorri, F., Colamarino, E., Masciullo, M., Morone, G., Toppi, J., Pisotta, I., Tamburella, F., Lorusso, M., Paolucci, S., Puopolo, M., and Cincotti, F.
- Subjects
Male ,030506 rehabilitation ,Longitudinal study ,Motor learning ,medicine.medical_treatment ,Brain plasticity ,EEG-based brain-computer interface ,Hand functional motor recovery ,Motor imagery ,Neurorehabilitation ,Stroke ,lcsh:RC346-429 ,law.invention ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine ,Longitudinal Studies ,Randomized Controlled Trials as Topic ,Rehabilitation ,Stroke Rehabilitation ,Electroencephalography ,General Medicine ,Middle Aged ,Brain-Computer Interfaces ,Imagination ,Female ,0305 other medical science ,Adult ,medicine.medical_specialty ,Modified Ashworth scale ,Motor Activity ,Upper Extremity ,03 medical and health sciences ,Physical medicine and rehabilitation ,Humans ,lcsh:Neurology. Diseases of the nervous system ,business.industry ,Recovery of Function ,medicine.disease ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
Background Stroke is a leading cause of long-term disability. Cost-effective post-stroke rehabilitation programs for upper limb are critically needed. Brain-Computer Interfaces (BCIs) which enable the modulation of Electroencephalography (EEG) sensorimotor rhythms are promising tools to promote post-stroke recovery of upper limb motor function. The “Promotoer” study intends to boost the application of the EEG-based BCIs in clinical practice providing evidence for a short/long-term efficacy in enhancing post-stroke hand functional motor recovery and quantifiable indices of the participants response to a BCI-based intervention. To these aims, a longitudinal study will be performed in which subacute stroke participants will undergo a hand motor imagery (MI) training assisted by the Promotoer system, an EEG-based BCI system fully compliant with rehabilitation requirements. Methods This longitudinal 2-arm randomized controlled superiority trial will include 48 first ever, unilateral, subacute stroke participants, randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and a hand MI training not supported by BCI. Both interventions are delivered (3 weekly session; 6 weeks) as add-on regimen to standard intensive rehabilitation. A multidimensional assessment will be performed at: randomization/pre-intervention, 48 h post-intervention, and at 1, 3 and 6 month/s after end of intervention. Primary outcome measure is the Fugl-Meyer Assessment (FMA, upper extremity) at 48 h post-intervention. Secondary outcome measures include: the upper extremity FMA at follow-up, the Modified Ashworth Scale, the Numeric Rating Scale for pain, the Action Research Arm Test, the National Institute of Health Stroke Scale, the Manual Muscle Test, all collected at the different timepoints as well as neurophysiological and neuroimaging measures. Discussion We expect the BCI-based rewarding of hand MI practice to promote long-lasting retention of the early induced improvement in hand motor outcome and also, this clinical improvement to be sustained by a long-lasting neuroplasticity changes harnessed by the BCI-based intervention. Furthermore, the longitudinal multidimensional assessment will address the selection of those stroke participants who best benefit of a BCI-assisted therapy, consistently advancing the transfer of BCIs to a best clinical practice. Trial registration Name of registry: BCI-assisted MI Intervention in Subacute Stroke (Promotoer). Trial registration number: NCT04353297; registration date on the ClinicalTrial.gov platform: April, 15/2020.
- Published
- 2020