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.
Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution