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Spinal implant aims to free ventilator-dependent patients from machines

NCT ID NCT04883463

Disease control Sponsor: University of California, Los Angeles 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests whether a spinal cord stimulator can safely help people with cervical spinal cord injuries breathe without a ventilator. Twelve adults who have been injured for at least a year and rely on a breathing machine will receive an implant and attend weekly sessions for up to 21 months. The main goal is to check safety, but researchers will also measure any improvements in breathing function.

What this could mean

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

Active substance
epidural electrical stimulation implant
What this could lead to
If it works, this could point toward a way for people with spinal cord injuries to breathe on their own, reducing or eliminating the need for a ventilator.
What could go wrong
This is a very small, early safety study with only 12 participants. The implant may not improve breathing, and there are risks from surgery and the device itself.

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

Sep 2021

Expected to finish

Dec 2028

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 75 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. Male or female 18-75 years 2. At least 1 year from initial cervical spinal cord injury 3. Non-progressive Spinal Cord Injury (SCI) at C2 - C7 (non-conus injury) 4. Motor Complete ASIA Impairment Scale (A, B, or C) 5. Severe respiratory function compromise requiring dependency on invasive or noninvasive ventilation 6. Able to attend weekly testing sessions for up to 21 months. 7. Have intact chest/lung, upper and lower extremity anatomy. The neuromuscular connections between the spinal cord and its effector muscles (respiratory and extremity) are required to be intact 8. Have intact cognitive ability, able to follow commands/voice concerns, and give consent Exclusion Criteria: 1. History of severe autonomic dysreflexia 2. Phrenic nerve or diaphragm pacer 3. Phrenic nerve paralysis 4. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer of grade 3 and above in the European Pressure Ulcer Advisory Panel Grading System, active infection 5. Clinically significant depression or ongoing drug abuse as documented in the medical record 6. Received lung surgery within one year prior to study enrollment or has active intrinsic lung disease (e.g. COPD, acute or chronic lung infection, moderate to severe asthma, emphysema, cystic fibrosis, etc.) 7. Cardiopulmonary disease that precludes training or rehabilitation 8. Other implanted stimulation devices 9. Pregnant 10. Severe cardiac disease (e.g. heart failure, atherosclerosis, arrhythmia, stroke, etc.) 11. Subjects involved in other clinical trials not associated with this trial 12. Botox injections in respiratory associated muscles within the last 3 months

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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

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

  • Semel Institute of Neuroscience at UCLA

    RECRUITING

    Los Angeles, California, 90024, United States

  • UCLA Clinical and Translational Research Center

    RECRUITING

    Los Angeles, California, 90095, United States

More trials for these conditions

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