Brain-controlled spinal stimulation to help arm and leg movement after chronic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this first-in-human feasibility study, researchers will connect motor cortex signals via an implanted 64-channel ECoG device to targeted epidural stimulation of the spinal cord, aiming to restore voluntary limb movements in adults with chronic subcortical or brain-stem stroke. The approach combines brain activity with spinal cord activation and pairs it with neurorehabilitation to promote motor recovery. Participants must meet specific motor, cognitive, and language criteria and undergo surgical implantation at a single center in Lausanne, Switzerland. The study will monitor safety and preliminary effectiveness in improving upper- and lower-limb function over time.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Jocelyne Bloch, MD — Chuv
• Study coordinator: Jocelyne Bloch, MD
• Email: jocelyne.bloch@chuv.ch
• Phone: +41 79 556 29 51

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.