Actively Recruiting
Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2025-10-07
3
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide signed informed consent before any study procedures
- Must be aged between 18 and 60 years at enrollment
- Must have a non-progressive traumatic spinal cord injury
- Must be classified as grade A, B, C, or D on the ASIA Impairment Scale
- Must have completed primary standard rehabilitation care
- Must have stable medical, physical, and psychological health
- Must have injury at or above T10 level with preserved conus function
- Must have sustained injury at least 12 months before consent
- Must have residual upper limb function to use a manual wheelchair
- Must be able to communicate in French or English with the study team
- Must agree to follow study rules and attend all visits
- Women of childbearing potential must use safe contraception
You will not qualify if you...
- Must not be pregnant or breastfeeding
- Must not plan to become pregnant during the study
- Must not have brain damage
- Must not have a history of epilepsy
- Must not have participated in another drug or device study within 30 days before or during this study
- Must not have received stem cell injections in the spinal cord
- Must not have blood disorders increasing surgical risk
- Must not require ventilator support
- Must not have walking limitations due to other nervous system disorders
- Must not have spinal cord injury from non-traumatic causes
- Must not have spinal stenosis or post-traumatic damage at implantation site
- Must not require an intrathecal baclofen pump
- Must not have pacemakers or defibrillators implanted
- Must not need Magnetic Resonance Imaging (MRI)
- Must not have congenital or acquired lower limb bone or joint abnormalities
- Must not be the investigator or related/dependent persons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
J
Jocelyne Bloch, MD
CONTACT
H
Henri Lorach, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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