Brain-controlled spinal cord stimulation for upper limb rehabilitation in cervical spinal cord injury

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

This clinical trial investigates the use of brain-controlled spinal cord stimulation to restore upper limb function in individuals with cervical spinal cord injury. The approach involves implanting an electrocorticography (ECoG) device that records brain signals to drive muscle-specific electrical stimulation in the spinal cord. The study aims to assess the safety and preliminary efficacy of this innovative system in three participants who have experienced severe impairment in upper limb function. By leveraging existing neural pathways, the trial seeks to reactivate motor functions that have been lost due to injury.

Why it matters

Who can join: the full rules

* Must provide Informed Consent as documented by signature (Appendix Informed Consent Form),
* Must be at least 18 years old and no older than 75 years old at the time of enrolment,
* Must be suffering from non-progressive traumatic cervical spinal cord injury,
* Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification,
* Must have completed primary standard of care rehabilitation,
* Must be severely impaired in his upper limb function as determined by the investigator,
* Must have sustained the injury at least 6 months before signing the consent form,
* 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 safe contraception for women of childbearing capacity,
* Must not be pregnant nor breast feeding,
* Must not have history of severe autonomic dysreflexia,
* Must not have brain damage,
* Must not have history of epilepsy,
* Must not have spinal stenosis,
* Must not have gastrointestinal ulcers in the last five years,
* Must not have any psychological disorder,
* Must not have the intention to become pregnant during the course of the study,
* Must not be known or suspected of drug or alcohol abuse,
* Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study,
* Must not have previously been injected with stem cells in the spinal cord,
* Must not be the investigator himself, his/her family members, employees or other dependent persons,
* Must not have any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator,
* Must not have any hematological disorders with increased risk for surgical intervention,
* Must not require ventilator support,
* Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc),
* Must not be subject to spasms that limit the ability of the subject to participate in the study training as determined by the investigator,
* Must not display spinal stenosis or post traumatic damage at location of implantation,
* Must not require the use of an intrathecal baclofen pump,
* Must not be implanted with a device such as pacemakers or defibrillators,
* Must not have any indication that would require an MRI,
* Must not suffer from congenital nor acquired upper limb abnormalities (affection of joints or bones).

Where it's running

• Chuv
  Lausanne, Canton of Vaud, Switzerland Recruiting

Study contacts

• 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.