The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with cervical and lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of upper and lower limbs in participants with chronic stroke suffering from mobility impairment.
The goal is to establish a direct bridge between the motor intention of the participant and the spinal cord, which should not only improve or restore voluntary control of arm and leg movement and support immediate mobility, but also promote neurological recovery when combined with neurorehabilitation.
Must be between 18-70 years old at the time of enrolment.
Must have suffered from a subcortical including brain stem stroke that occurred at least 9 months but not more than 10 years prior to enrolment.
Must have a score lower than 25 on the Fugl-Meyer upper-limb scale.
Must be able to stand with or without assistive device for 30 seconds.
Must not be pregnant or breast feeding (if applicable).
Must not have the intention to become pregnant during the study (if applicable).
Must not have any diseases and conditions that would increase the morbidity and mortality of the implantation surgery.
Must not have any mental instability, including a diagnosis of personality disorder, psychosis, substance abuse, or severe depression as assessed by the psychologist.
Single group
ARC-BSI Stroke system
DeviceImplantation of a 64 channel - ECoG array over the sensory motor cortex of one side's upper and lower limbs, combined with an implantation of two 16 channel spinal cord stimulation system, one over the cervical region and one over the lumbar region. The decoded motor intentions are driving the implanted spinal cord stimulation system. Brain-controlled spinal cord stimulation is used for training and rehabilitation to recover voluntary movements.
Preliminary safety
Occurrence of Serious Adverse Events (SAE) and Adverse Events (AE) that are deemed related or possibly related to the procedure or to the ARC-BSI Stroke System.
Fugl-Meyer Assessment Lower Extremities
A performance-based measure used to assess motor functioning, balance, sensation, joint range of motion and joint pain in upper and lower limbs of stroke patients.
10 Meters Walk Test (10MWT)
Clinical measure to assess walking speed (in m/s) over 10 meters.
6 Minute Walk Test (6MWT):
Submaximal test to assess endurance during 6 minutes of walking.
Timed Up and Go (TUG):
Timed test of functional mobility (stand-up, walk, turn around, sit-down)
Stroke-Specific Quality of Life (SS-QOL)
The SS-QOL assesses health-related quality of life specific to stroke survivors. It considers different areas including behavior, cognition, functional mobility, language, negative affect, personality, quality of life, social relationships, and upper extremity function. This questionnaire will help the investigators to evaluate the areas in which the participant is most affected and determine if there is an evolution during the study.
Psychosocial Impact of Assistive Device Scale (PIADS)
The PIADS is a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life
Stroke Impact Scale (SIS)
A self-report questionnaire that evaluates disability and health-related quality of life after stroke. It assesses different areas including activities of daily living, cognition, communication, depression, function mobility, gait, general health, life participation, quality of life, social relationships, social support, and upper extremity function.
Goal Attainment Scaling (GAS)
A method of scoring the extent to which patient's individual goals are achieved during intervention. In effect, each patient has their own outcome measure, but this is scored in a standardized way to allow statistical analysis.
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Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
