Spinal cord zap may help people breathe again after neck injury
NCT ID NCT07722130
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
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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
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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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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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
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The First Affiliated Hospital of Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210009, China
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Zhongda Hospital, Southeast University
RECRUITINGNanjing, Jiangsu, 210009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Automated oxygen delivery by O2matic to patients admitted with an exacerbation in COPD
- Can a battery keep ventilators running during ambulance transport?
- Can magnetic pulses to the brain restore hand control after spinal injury?
- Can a simple ultrasound combo predict breathing failure before it happens?
- Could stepping down breathing support sooner save more lives?
- Can new home monitors keep tabs on breathing support without a clinic visit?