Rehabilitation and Biomarkers of Stroke Recovery: Study Protocol for a Randomized Controlled Trial

Picelli, Alessandro; Filippetti, Mirko; Piccolo, Lidia Del; Schena, Federico; Chelazzi, Leonardo; Libera, Chiara Della; Donadelli, Massimo; Donisi, Valeria; Fabene, Paolo F.; Fochi, Stefania; Fonte, Cristina; Gandolfi, Marialuisa; Gómez-Lira, Macarena; Locatelli, Elena; Malerba, Giovanni; Mariotto, Sofia; Milanese, Chiara; Patuzzo, Cristina; Sbarbati, Andrea; Tamburin, Stefano; Venturelli, Massimo; Zamparo, Paola; Prati, Alessandra Carcereri de; Butturini, Elena; Varalta, Valentina; Smania, Nicola

doi:10.3389/fneur.2020.618200

Cited by 3 publications

(6 citation statements)

References 27 publications

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“…Based only on clinical scales (without biomarker information about the corticospinal tract), the potential for a good recovery of function might go unrecognized by clinicians. Referring to multimodal panels of stroke recovery biomarkers, it is necessary to mention a very promising ongoing study of Picelli et al, where the study protocol for a randomized controlled trial is being developed [74]. The study will allow definition of a set of biomarkers (including neuroimaging: diffusion tensor imaging (DTI) and functional magnetic resonance imaging (fMRI); and neurophysiological: motor evoked potentials (MEP) and intracortical excitability measured by single and paired transcranial magnetic stimulation (TMS); somatosensory evoked potentials (SEP); and brain connectivity measured by electroencephalographic (EEG) phase synchrony) related to stroke recovery and rehabilitation result in order to discover patients with stronger potential for improvement and define personalized rehabilitation programs.…”

Section: Future Directions-multimodal Panels Of Neuroimaging Biomarke...mentioning

confidence: 99%

Neuroimaging Techniques as Potential Tools for Assessment of Angiogenesis and Neuroplasticity Processes after Stroke and Their Clinical Implications for Rehabilitation and Stroke Recovery Prognosis

Włodarczyk

Cichoń

Saluk‐Bijak

et al. 2022

JCM

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Stroke as the most frequent cause of disability is a challenge for the healthcare system as well as an important socio-economic issue. Therefore, there are currently a lot of studies dedicated to stroke recovery. Stroke recovery processes include angiogenesis and neuroplasticity and advances in neuroimaging techniques may provide indirect description of this action and become quantifiable indicators of these processes as well as responses to the therapeutical interventions. This means that neuroimaging and neurophysiological methods can be used as biomarkers—to make a prognosis of the course of stroke recovery and define patients with great potential of improvement after treatment. This approach is most likely to lead to novel rehabilitation strategies based on categorizing individuals for personalized treatment. In this review article, we introduce neuroimaging techniques dedicated to stroke recovery analysis with reference to angiogenesis and neuroplasticity processes. The most beneficial for personalized rehabilitation are multimodal panels of stroke recovery biomarkers, including neuroimaging and neurophysiological, genetic-molecular and clinical scales.

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Section: Future Directions-multimodal Panels Of Neuroimaging Biomarke...mentioning

confidence: 99%

Neuroimaging Techniques as Potential Tools for Assessment of Angiogenesis and Neuroplasticity Processes after Stroke and Their Clinical Implications for Rehabilitation and Stroke Recovery Prognosis

Włodarczyk

Cichoń

Saluk‐Bijak

et al. 2022

JCM

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“…In particular, the development of potential biomarkers could lead to a further stratification of the patient population into smaller subgroups (Habermehl et al, 2018), which affects directly the sample size and the stratification criteria of the clinical study Different strategies for improving trial quality are being proposed, which include new methods to the selection of patients, control interventions, and endpoint measures. For example, single blind, randomized, controlled (parallel-group) trials focused on defining a set of biomarkers related to long term recovery after stroke has been recently proposed (Picelli et al, 2020). Aspects like the experimental design and sample size are being addressed in fMRI-based biomarkers for multiple sclerosis (Hu et al, 2020) There is a lack of correlation between biomarkers and clinical scales…”

Section: Small Sample Sizementioning

confidence: 99%

“…In particular, the creation of the FDA Biomarkers Working Group has produced standards that focus on current issues related to biomarker development and regulatory acceptance (FDA-NIH Biomarker Working Group, 2016), and to create processes and policies that could help to address the challenges associated with these issues Furthermore, multidisciplinary tools for biomarkers development such as the EVIDENCE (EValuatIng connecteD sENsor teChnologiEs) checklist (Manta et al, 2021) are promoting high quality reporting in studies where the main goal is the assessment of a digital measurement. These type of guidelines are crucial for integrating clinical sciences, data management, technology development, and biostatistics into the deployment of biomarkers Frontiers in Neurorobotics | www.frontiersin.org the rehabilitation-relevant biomarkers (Gao et al, 2018;Zhang et al, 2019;Picelli et al, 2020). This approach could lead to the potential development of reliable one-off measures to evaluate the functionality of a single patient by developing a biomarker profile in which a reference value is present.…”

Section: Complex Regulatory Scenario To Integrate Biomarkers Into Medical Devicesmentioning

confidence: 99%

“…Following the notion that the robot-assisted neurorehabilitation demands a highly patient-tailored process, which entails the identification of the unique needs, priorities, and recovery profile of the patient, the integration of the biomarkers belonging to the different domains (sensorimotor, cognitive-behavioral, autonomic, psychological, and psychosocial) is being undertaken (Bui and Johnson, 2018 ; Zariffa, 2018 ; Picelli et al, 2020 ). The idea of developing the profile of the patient that combines the relevance of the multifactorial biomarkers is a new approach that is starting to being explored, with the design of the dedicated study protocols for defining a related profile of the biomarkers of long-term recovery after stroke (Picelli et al, 2020 ) and the exploration of the novel biomarkers related to the other aspects of the motor function rather than sensorimotor such as alterations in the body representations (Maggio et al, 2021 ), eye–hand coupling assessment (Rizzo et al, 2017 ), quantification of visuospatial neglect (VSN) (Svaerke et al, 2019 ), and somatic (or cognitive-related) biomarkers (Martinez-Pernia, 2020 ). Additionally, the combination of the neuroimaging technologies is supporting this multifactorial exploration by combining EMG, EEG, and inertial data to obtain the rehabilitation-relevant biomarkers (Gao et al, 2018 ; Zhang et al, 2019 ; Picelli et al, 2020 ).…”

Section: Latest Trends and Perspectives In The Fieldmentioning

confidence: 99%

“…The idea of developing the profile of the patient that combines the relevance of the multifactorial biomarkers is a new approach that is starting to being explored, with the design of the dedicated study protocols for defining a related profile of the biomarkers of long-term recovery after stroke (Picelli et al, 2020 ) and the exploration of the novel biomarkers related to the other aspects of the motor function rather than sensorimotor such as alterations in the body representations (Maggio et al, 2021 ), eye–hand coupling assessment (Rizzo et al, 2017 ), quantification of visuospatial neglect (VSN) (Svaerke et al, 2019 ), and somatic (or cognitive-related) biomarkers (Martinez-Pernia, 2020 ). Additionally, the combination of the neuroimaging technologies is supporting this multifactorial exploration by combining EMG, EEG, and inertial data to obtain the rehabilitation-relevant biomarkers (Gao et al, 2018 ; Zhang et al, 2019 ; Picelli et al, 2020 ).…”

Section: Latest Trends and Perspectives In The Fieldmentioning

confidence: 99%

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Neuromechanical Biomarkers for Robotic Neurorehabilitation

et al. 2021

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One of the current challenges for translational rehabilitation research is to develop the strategies to deliver accurate evaluation, prediction, patient selection, and decision-making in the clinical practice. In this regard, the robot-assisted interventions have gained popularity as they can provide the objective and quantifiable assessment of the motor performance by taking the kinematics parameters into the account. Neurophysiological parameters have also been proposed for this purpose due to the novel advances in the non-invasive signal processing techniques. In addition, other parameters linked to the motor learning and brain plasticity occurring during the rehabilitation have been explored, looking for a more holistic rehabilitation approach. However, the majority of the research done in this area is still exploratory. These parameters have shown the capability to become the “biomarkers” that are defined as the quantifiable indicators of the physiological/pathological processes and the responses to the therapeutical interventions. In this view, they could be finally used for enhancing the robot-assisted treatments. While the research on the biomarkers has been growing in the last years, there is a current need for a better comprehension and quantification of the neuromechanical processes involved in the rehabilitation. In particular, there is a lack of operationalization of the potential neuromechanical biomarkers into the clinical algorithms. In this scenario, a new framework called the “Rehabilomics” has been proposed to account for the rehabilitation research that exploits the biomarkers in its design. This study provides an overview of the state-of-the-art of the biomarkers related to the robotic neurorehabilitation, focusing on the translational studies, and underlying the need to create the comprehensive approaches that have the potential to take the research on the biomarkers into the clinical practice. We then summarize some promising biomarkers that are being under investigation in the current literature and provide some examples of their current and/or potential applications in the neurorehabilitation. Finally, we outline the main challenges and future directions in the field, briefly discussing their potential evolution and prospective.

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Stroke biomarkers: Issues of diagnosis and medical rehabilitation

Пономарев

Polyakova

Prokhorova

et al. 2022

Physical and rehabilitation medicine, medical rehabilitation

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Stroke is the main death and invalidization factor throughout the world. Stroke prevention, early diagnostics and treatment, as well as proper rehabilitation, are the key research directions to reduce death and invalidization numbers. Current clinical practice widely uses many biochemical markers (biomarkers) found in blood, urine or cerebrospinal fluid to make therapeutic decisions. Used along with standard examination methods, the potential benefit of stroke biomarkers could be seen in stroke type differential diagnostics, complication development forecasting and rehabilitation events personification. Many potential stroke biomarkers and combined panels, including those used for rehabilitation intensity estimation, are described in science literature. Among them prevail peptide molecules connected with the damage of neurons and their axons, neuroglia, brain vessels endothelium. Less attention is given to blood proteins, lipids and other metabolites. There appears more and more reliable data on circulating nucleic acids as stroke manifestation and progress markers. Despite obvious clinical and economical biomarkers prospects, no studied stroke markers are used in everyday clinical practice. That could be caused by obtained suboptimal sensitivity and specificity indicators and difficulties with translational studies organization and conducting. Relevance of stroke biomarkers as a way to control rehabilitation intensity also highlights the necessity to additional researches.

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Rehabilitation and Biomarkers of Stroke Recovery: Study Protocol for a Randomized Controlled Trial

Cited by 3 publications

References 27 publications

Neuroimaging Techniques as Potential Tools for Assessment of Angiogenesis and Neuroplasticity Processes after Stroke and Their Clinical Implications for Rehabilitation and Stroke Recovery Prognosis

Neuroimaging Techniques as Potential Tools for Assessment of Angiogenesis and Neuroplasticity Processes after Stroke and Their Clinical Implications for Rehabilitation and Stroke Recovery Prognosis

Neuromechanical Biomarkers for Robotic Neurorehabilitation

Stroke biomarkers: Issues of diagnosis and medical rehabilitation

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