Using brain-controlled spinal cord stimulation to help people with spinal cord injuries walk again

Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation

This study is testing a new way to help people with spinal cord injuries walk again by using a device that connects their brain signals to the spinal cord to improve movement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Ecole Polytechnique Fédérale de Lausanne (Academic / other)
• Locations: 1 site (Lausanne, Canton of Vaud)
• Trial ID: NCT06243952 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and effectiveness of a novel approach that combines a cortical recording device with targeted epidural electrical stimulation of the spinal cord. The goal is to create a direct link between the participant's motor intentions and the spinal cord below the injury, potentially restoring voluntary movement in the lower limbs. Participants will undergo a rehabilitation program that integrates this technology to enhance mobility and promote neurological recovery. The study focuses on individuals with chronic spinal cord injuries who have completed standard rehabilitation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with non-progressive traumatic spinal cord injuries graded A, B, C, or D on the ASIA Impairment Scale.

Not a fit: Patients with progressive spinal cord injuries or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with spinal cord injuries.

How similar studies have performed: Previous studies have shown promise with similar approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Must provide Informed Consent as documented by signature (Appendix Informed Consent Form) prior to any study-related procedures,
2. Must be at least 18 years old and no older than 60 years old at the time of enrolment,
3. Must be suffering from non-progressive traumatic spinal cord injury,
4. Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification,
5. Must have completed primary standard of care rehabilitation,
6. Must have stable medical, physical and psychological condition as considered by the investigator,
7. Must be lesioned at T10 or above, based on AIS level determination by the investigator, with preservation of conus function,
8. Must have sustained the injury at least 12 months before signing the consent form,
9. Must have residual upper limb function (capable of using a manual wheelchair),
10. Must be able to understand and interact with the study team in French or English,
11. Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments,
12. Must use safe contraception for women of childbearing capacity.

Exclusion Criteria:

1. Must not be pregnant nor breast feeding,
2. Must not have the intention to become pregnant during the course of the study,
3. Must not have brain damage,
4. Must not have history of epilepsy,
5. Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study,
6. Must not have previously been injected with stem cells in the spinal cord,
7. Must not have any hematological disorders with increased risk for surgical intervention,
8. Must not require ventilator support,
9. Must not have limitation of walking function based on accompanying (Central Nervous System (CNS)) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders),
10. Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc.),
11. Must not display spinal stenosis or post traumatic damage at location of implantation,
12. Must not require the use of an intrathecal baclofen pump,
13. Must not be implanted with a device such as pacemakers or defibrillators,
14. Must not have any indication that would require Magnetic Resonance Imaging (MRI),
15. Must not suffer from congenital nor acquired lower limb abnormalities (affection of joints or bones).
16. Must not be the investigator himself, his/her family members, employees or other dependent persons.

Where this trial is running

Lausanne, Canton of Vaud

• Chuv — Lausanne, Canton of Vaud, Switzerland (Recruiting)

Study contacts

• Principal investigator: Jocelyne Bloch, MD — Chuv
• Study coordinator: Jocelyne Bloch, MD

Conditions Spinal Cord Injuries; Paraplegia; Spinal cord stimulation; Brain computer interface; Brain spine interface