Mind over paralysis: Brain-Spine bridge aims to restore leg movement
NCT ID NCT06243952
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This study tests a device that reads brain signals and sends them to the spinal cord to help people with chronic spinal cord injury move their legs. Three participants will use the system during rehabilitation to see if it is safe and can improve walking. The goal is to create a direct link between thought and movement, bypassing the injury.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 3 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, except for VALSE study conducted at CHUV, 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHUV
Lausanne, Canton of Vaud, 1011, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Serotonin precursor probed for spinal cord injury effects
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?