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

Recruiting now · Not applicable

Conditions studied: Stroke, Hemiplegia

In brief

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 facts

Study ID

NCT07610850

Run by

Ecole Polytechnique Fédérale de Lausanne

People needed

3

Starts

2026-09-01

Expected to finish

2032-10-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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