Spinal implant upgrade aims to get people walking again

NCT ID NCT05942339

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • CHUV

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

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