Spinal implant upgrade aims to get people walking again
NCT ID NCT05942339
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new spinal implant system (ARC-IM Lumbar) in 8 people with chronic spinal cord injury who already have a spinal implant. The goal is to improve walking, bladder, bowel, and sexual function, and make the system easier to use at home. Participants will be followed for up to 36 months to check safety and effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Aug 2027
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 65 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings. 2. Age 18-65 3. SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C \& D 4. SCI ≥ 12months 5. SCI lesion level T10 and above with preservation of conus function 6. SCI due to trauma 7. Stable medical, physical and psychological condition as considered by the investigators 8. Able to understand and interact with the study team in French or English 9. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments 10. Must provide and sign the Informed Consent prior to any study-related procedures Exclusion Criteria: 1. Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery 2. History of myocardial infarction or cerebrovascular event within the past 6 months 3. Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders) 4. Any active implanted cardiac device such as pacemaker or defibrillator 5. Any indication that would require diathermy 6. Any indication that would require MRI 7. Any anatomical limitations in the implantation area as judged by the investigators 8. Other conditions that would make the subject unable to participate in testing in the judgement of the investigators 9. Clinically significant mental illness in the judgement of the investigators 10. Presence of indwelling baclofen or insulin pump 11. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) 12. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant 13. Enrolment of the investigator, his/her family members, employees, and other dependent persons 14. Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHUV
RECRUITINGLausanne, Canton of Vaud, 1011, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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?
- Can painless spinal zaps teach injured kids to walk again?