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NCT07610850

Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation

Sponsor: Ecole Polytechnique Fédérale de Lausanne

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-01

Completion Date

2032-04

Last Updated

2026-05-28

Healthy Volunteers

Conditions

Stroke Hemiplegia

Interventions

DEVICE

ARC-BSI Stroke system

Implantation 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.

Inclusion Criteria: * 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 have a score higher than 22 at the Montreal Cognitive Assessment. * Must present right or left hemiplegia. * Must have completed primary standard of care rehabilitation. * Must provide and sign the study's Informed Consent prior to any study-related procedures. * Must be able to understand and interact with the study team in French or English. * Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments. * Must use effective contraception for women of childbearing capacity. * Must be able to withhold antiplatelet/anticoagulation agents perioperatively for the time of the surgeries (if applicable). Exclusion Criteria: * 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. * Must not have any other medical conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., major cognitive disorder, renal failure, hepatic dysfunction, epilepsy, etc.). * Must not have ongoing significant dysphagia or aspiration difficulties or require ventilator support. * Must not have any active implanted device, such as a pacemaker or other neurostimulator. * Must not have any spinal anatomical abnormalities or incompatibilities with the implanted system precluding surgery. * Must not have severe spasticity of the upper limb or lower limb (Modified Ashworth Scale \> 3). * Must not have indication requiring frequent MRIs. * Must not participate in another clinical study using drugs or medical devices that might interfere with the outcomes of the study. * Must not be the investigator him/herself, his/her family members, employees, and other dependent persons.