Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation
Ecole Polytechnique Fédérale de Lausanne
3 participants
May 3, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of lower limbs in participants with chronic spinal cord injury suffering from mobility impairment. The goal is to establish a direct bridge between the motor intention of the participant and the the spinal cord below the lesion, which should not only improve or restore voluntary control of legs movement and support immediate locomotion, but also promote neurological recovery when combined with neurorehabilitation.
Eligibility
Inclusion Criteria12
- Must provide Informed Consent as documented by signature (Appendix Informed Consent Form) prior to any study-related procedures,
- Must be at least 18 years old and no older than 60 years old at the time of enrolment,
- Must be suffering from non-progressive traumatic 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 have stable medical, physical and psychological condition as considered by the investigator,
- Must be lesioned at T10 or above, based on AIS level determination by the investigator, with preservation of conus function,
- Must have sustained the injury at least 12 months before signing the consent form,
- Must have residual upper limb function (capable of using a manual wheelchair),
- 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.
Exclusion Criteria16
- Must not be pregnant nor breast feeding,
- Must not have the intention to become pregnant during the course of the study,
- Must not have brain damage,
- Must not have history of epilepsy,
- 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 have any hematological disorders with increased risk for surgical intervention,
- Must not require ventilator support,
- 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),
- Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc.),
- 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 Magnetic Resonance Imaging (MRI),
- Must not suffer from congenital nor acquired lower limb abnormalities (affection of joints or bones).
- Must not be the investigator himself, his/her family members, employees or other dependent persons.
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Interventions
Implantation of a 64 channel - ECoG array over the sensory motor cortex of the lower limbs, combined with an implantation of 16 channel spinal cord stimulation system over the lumbar region. The decoded motor intentions are driving the implanted spinal cord stimulation system. Brain-controlled spinal cord stimulation is used for training and rehabilitation to recover voluntary movements.
Locations(1)
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NCT06243952