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

Sponsor
Ecole Polytechnique Fédérale de Lausanne
Study ID
NCT07610850
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ARC-BSI Stroke system — DEVICE
    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.

Study Details

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 Dates

First listed
May 28, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2032

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All participants
    All participants receive the same intervention.

Primary Outcome Measure

Preliminary safety [ Time Frame: From enrollment until End of the Study timepoint (at 5 years) ]

Central Contacts

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