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Spinal implant aims to restore walking in paralyzed patients

NCT ID NCT07306052

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a device that sends electrical pulses to the spinal cord, combined with daily rehab, to help people with chronic spinal cord injury regain walking ability. Twelve participants will receive the implant and be followed for over a year. The goal is to see if the approach is safe and improves walking and independence.

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.

Started

Dec 2025

Expected to finish

Jun 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

16 to 70 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: * Age between 16 and 70 years. * Diagnosed with traumatic spinal cord injury for ≥ 6 months and ≤ 60 months. * American Spinal Injury Association Impairment Scale (AIS) grade B-D. * Spinal cord injury level above T10; * Walking Index for Spinal Cord Injury II (WISCI II) score ≤ 13. * Completion of a standard conventional rehabilitation program prior to enrollment. * Preserved upper limb function sufficient for self-propelling a manual wheelchair. * Sitting balance grade ≥ 1. * Ability to elicit clear electromyographic responses in lower limb muscles (e.g., rectus femoris, biceps femoris, gastrocnemius, tibialis anterior) upon transcutaneous electrical spinal cord stimulation at the T12-L1 vertebral levels. * Willingness to voluntarily participate, and commitment to compliance with all necessary postoperative rehabilitation, assessments, and follow-up visits. Exclusion Criteria: * History of myocardial infarction or stroke within the past 6 months. * Diagnosis of psychiatric disorders with active suicidal ideation or risk. * Current pregnancy or planned pregnancy during the study period. * Bleeding tendency or coagulopathy (prothrombin time ≥18 seconds). * History of alcohol or substance abuse or dependence. * Intellectual disability, cognitive impairment, or personality disorders. * Other chronic medical conditions that may interfere with rehabilitation (e.g., unhealed severe fractures, hepatic or renal failure, severe anemia, etc.). * Implantation of cardiac pacemakers, cardioverters, or defibrillators. * Any other condition deemed inappropriate for participation by the investigators.

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injuries (SCI)

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.

    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

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.