Spinal cord zap may help people breathe again after neck injury

NCT ID NCT07722130

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This trial tests whether a device that sends mild electrical pulses to the spinal cord can help people with a cervical spinal cord injury breathe more independently. Twenty adults with a C1-C5 injury who need a ventilator will have electrodes implanted near the injury site and receive daily stimulation. The study measures changes in diaphragm activity, breathing volume, and time off the ventilator to see if this approach is safe and worth testing in larger trials.

What this could mean

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

Active substance
cervical epidural spinal cord stimulation
What this could lead to
If it works, this approach could help people with high spinal cord injuries breathe on their own, reducing or eliminating the need for a ventilator.
What could go wrong
This is a small, early exploratory trial with only 20 participants. The surgery to implant electrodes carries risks, and the stimulation may not improve breathing enough to make a real difference.

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 20 people

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

Started

Jun 2026

Expected to finish

Mar 2029

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. Age between 18 and 75 years, with BMI \<30 kg/m². 2. Cervical SCI involving levels C1-C5 for at least 2 weeks. 3. Respiratory failure defined by one or more of the following: * Peripheral oxygen saturation \<90% on room air; * Arterial oxygen tension (PaO₂) \<60 mmHg; * Respiratory acidosis (PaCO₂ \>45 mmHg with pH \<7.35); * Requirement for mechanical ventilation. 4. Maximum inspiratory pressure (MIP) \>-15 cmH₂O. 5. Judged by the treating physician to be unable to tolerate continuous ventilator weaning for ≥48 hours due to SCI. 6. Written informed consent provided by the participant or legally authorized representative. Exclusion Criteria: 1. Active infection at the planned electrode implantation site, severe systemic infection, or existing implanted neurostimulation devices. 2. Respiratory failure primarily caused by severe pneumonia, pulmonary contusion, pneumothorax, hemothorax, chronic obstructive pulmonary disease, or requirement for home oxygen therapy within the previous 6 months. 3. New York Heart Association (NYHA) class III or IV heart failure or implanted cardiac pacemaker. 4. Severe hepatic or renal dysfunction (Child-Pugh class C liver disease or estimated glomerular filtration rate ≤30 mL/min/1.73 m²) or dialysis dependence. 5. Generalized seizures, traumatic brain injury, intracranial hypertension, intracranial aneurysm with Glasgow Coma Scale score ≤12, or neuromuscular disorders affecting respiratory function. 6. Expected survival \<72 hours or refusal of life-sustaining treatment. 7. Pregnancy or breastfeeding. 8. Any other condition considered by the investigator to make study participation inappropriate.

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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

  • The First Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Zhongda Hospital, Southeast University

    RECRUITING

    Nanjing, Jiangsu, 210009, China

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