Brain Controlled Spinal Cord Stimulation in Participants with Spinal Cord Injury for Lower Limb Rehabilitation

Launched by ECOLE POLYTECHNIQUE FÉDÉRALE DE LAUSANNE · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new method to help people with spinal cord injuries regain movement in their legs. The study is using a special device that records brain signals, combined with targeted electrical stimulation of the spinal cord, to create a direct connection between the participant's brain and the nerves that control leg movement. The aim is to improve voluntary control over leg movements, help with walking, and support overall recovery when combined with rehabilitation exercises.

To participate in this trial, individuals must be between 18 and 60 years old, have a stable spinal cord injury that is at least 12 months old, and still have some function in their upper limbs. They also need to be able to understand and communicate in either French or English. Participants can expect to receive close monitoring and care throughout the study, and they will need to attend regular appointments. Importantly, those interested should be aware that certain medical conditions or devices, such as pregnancy or implanted devices like pacemakers, may exclude them from participating.

Gender

ALL

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.