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Spinal implant aims to restore walking in paralysis patients

NCT ID NCT07234903

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study is testing a device called ARC-IM Therapy, which delivers electrical impulses to the lower spinal cord, to see if it can help people with spinal cord injury regain the ability to walk. The trial will include 12 adults with recent or long-term injuries. The main goal is to check safety, but researchers will also measure any improvements in walking and nerve function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARC-IM Lumbar System (epidural electrical stimulation device)
What this could lead to
If it works, this could point toward a way to help people with spinal cord injury regain some walking ability.
What could go wrong
This is a very early, small study (12 people) focused on safety. It may not lead to a proven treatment, and there are risks from the implantation procedure and stimulation.

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 12 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2032

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. Must be at least 18 years old and no older than 65 years old at the time of enrollment. 2. Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS). 3. Must have a SCI level at T10 or higher as determined by ISNCSCI, with the region extending 6 cm above the tip of the conus remaining anatomically intact as determined by MRI. 4. Must have sustained their injury either less than 6 weeks prior to baseline (Group "Subacute SCI"), or more than 1 year prior to enrollment (Group "Chronic SCI"). 5. Must be suffering from a SCI due to trauma. 6. Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists. 7. Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration). 8. Must be able to understand and interact with the study team in German, French or English. 9. Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments. 10. Must provide Informed Consent as documented by signature prior to any study-related procedures. 11. Must have an acceptable or highly effective method of contraception for women of childbearing capacity. Exclusion Criteria: 1. Must not be pregnant nor breastfeeding. 2. Must not have brain damage. 3. Must not have a history of epilepsy 4. Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study. 5. Must not have previously been injected with stem cells in the spinal cord. 6. Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery. 7. Must not require ventilator support. 8. Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.). 9. Must not suffer from SCI from other etiology than trauma (ischemic, tumoral, autoimmune, etc.). 10. Must not have any anatomical limitations in the implantation area as judged by the investigators (e.g., spinal stenosis, limiting protrusions, post-traumatic bone damage at area of implantation). 11. Must not require the use of an intrathecal baclofen pump. 12. Must not have any active implanted devices. 13. Must not have any other conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.). 14. Must not be the investigator him/herself, 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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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.

    Open the record ↗

  3. 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

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Schweizer Paraplegiker-Zentrum (SPZ)

    NOT_YET_RECRUITING

    Nottwil, Canton of Lucerne, 6207, Switzerland

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