A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol

Claudia Bigoni; Sarah B Zandvliet; Elena Beanato; Andrea Crema; Martina Coscia; Arnau Espinosa; Tina Henneken; Julie Hervé; Meltem Oflar; Giorgia G Evangelista; Takuya Morishita; Maximilian J Wessel; Christoph Bonvin; Jean-Luc Turlan; Niels Birbaumer; Friedhelm C Hummel

doi:10.3389/fneur.2022.919511

A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol

Front Neurol. 2022 Jul 7:13:919511. doi: 10.3389/fneur.2022.919511. eCollection 2022.

Authors

Claudia Bigoni^{1

2}, Sarah B Zandvliet^{1

2

3}, Elena Beanato^{1

2}, Andrea Crema^{4

5}, Martina Coscia^{6

7}, Arnau Espinosa⁶, Tina Henneken^{1

2}, Julie Hervé^{1

2}, Meltem Oflar^{1

2}, Giorgia G Evangelista^{1

2}, Takuya Morishita^{1

2}, Maximilian J Wessel^{1

2}, Christoph Bonvin⁸, Jean-Luc Turlan⁹, Niels Birbaumer¹⁰, Friedhelm C Hummel^{1

2

4}

Affiliations

¹ Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), École Polytechnique Fédérale de Lausanne (EPFL), Geneva, Switzerland.
² Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), École Polytechnique Fédérale de Lausanne (EPFL), Clinique Romande de Réadaptation, Sion, Switzerland.
³ Department of Rehabilitation, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, Netherlands.
⁴ Clinical Neuroscience, University of Geneva Medical School, Geneva, Switzerland.
⁵ Bertarelli Foundation Chair in Translational Neuroengineering, Centre for Neuroprosthetics and Institute of Bioengineering, School of Engineering, École Polytechnique Fédérale de Lausanne (EPFL), Lausanne, Switzerland.
⁶ Wyss Center for Bio and Neuroengineering, Geneva, Switzerland.
⁷ confinis AG, Sursee, Switzerland.
⁸ Division of Neurology, Wallis Hospital, Sion, Switzerland.
⁹ Department of Neurological Rehabilitation, Clinique Romande de Réadaptation Suva, Sion, Switzerland.
¹⁰ Department of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Tübingen, Germany.

Abstract

Effective, patient-tailored rehabilitation to restore upper-limb motor function in severely impaired stroke patients is still missing. If suitably combined and administered in a personalized fashion, neurotechnologies offer a large potential to assist rehabilitative therapies to enhance individual treatment effects. AVANCER (clinicaltrials.gov NCT04448483) is a two-center proof-of-concept trial with an individual based cumulative longitudinal intervention design aiming at reducing upper-limb motor impairment in severely affected stroke patients with the help of multiple neurotechnologies. AVANCER will determine feasibility, safety, and effectivity of this innovative intervention. Thirty chronic stroke patients with a Fugl-Meyer assessment of the upper limb (FM-UE) <20 will be recruited at two centers. All patients will undergo the cumulative personalized intervention within two phases: the first uses an EEG-based brain-computer interface to trigger a variety of patient-tailored movements supported by multi-channel functional electrical stimulation in combination with a hand exoskeleton. This phase will be continued until patients do not improve anymore according to a quantitative threshold based on the FM-UE. The second interventional phase will add non-invasive brain stimulation by means of anodal transcranial direct current stimulation to the motor cortex to the initial approach. Each phase will last for a minimum of 11 sessions. Clinical and multimodal assessments are longitudinally acquired, before the first interventional phase, at the switch to the second interventional phase and at the end of the second interventional phase. The primary outcome measure is the 66-point FM-UE, a significant improvement of at least four points is hypothesized and considered clinically relevant. Several clinical and system neuroscience secondary outcome measures are additionally evaluated. AVANCER aims to provide evidence for a safe, effective, personalized, adjuvant treatment for patients with severe upper-extremity impairment for whom to date there is no efficient treatment available.

Keywords: brain computer interface; personalized; rehabilitation; stroke; tDCS; upper limb.

Associated data

ClinicalTrials.gov/NCT04448483