Spinal zaps could reboot breathing after brain injury
NCT ID NCT07766681
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial tests whether epidural spinal cord stimulation can help people with severe brain injury breathe without a ventilator. Ten patients with stroke or traumatic brain injury who need mechanical ventilation will receive a surgically implanted electrode that delivers electrical pulses to the spinal cord. Researchers will measure diaphragm activity, breathing function, and safety outcomes to see if this approach can improve respiratory recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Epidural spinal cord stimulation (a surgically implanted electrode that delivers electrical pulses to the spinal cord)
- What this could lead to
- If it works, this could offer a new way to help brain injury patients regain spontaneous breathing and reduce time on ventilators.
- What could go wrong
- This is a very small, early exploratory study, so results may not apply broadly. Surgery and stimulation carry risks like infection, bleeding, or nerve damage, and the approach may not improve breathing in all patients.
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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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 74 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: * Age 18 to 74 years. Body mass index less than 30 kg/m². Imaging-confirmed stroke or traumatic brain injury. Glasgow Coma Scale score of 3 to 8, with relatively stable vital signs. Requirement for invasive mechanical ventilation through an oral or nasal endotracheal tube or tracheostomy for at least 24 hours. Written informed consent provided by the participant's legally authorized representative; if the participant regains decision-making capacity, continued participation will be reconfirmed with the participant. Willingness and ability of the participant or legally authorized representative to comply with the study intervention and follow-up procedures. Exclusion Criteria: * Suspected or confirmed infection at the planned electrode implantation site, severe uncontrolled systemic infection, known metal allergy relevant to the implanted device, or uncontrolled intracranial hypertension. Respiratory failure primarily attributable to severe pneumonia, pulmonary contusion, pneumothorax, hemothorax, chronic obstructive pulmonary disease with respiratory failure, severe asthma, or a requirement for home oxygen therapy within the previous 6 months. New York Heart Association class III or IV heart failure or presence of an implanted cardiac pacemaker. Severe hepatic dysfunction, including Child-Pugh class C, severe renal dysfunction with estimated glomerular filtration rate ≤30 mL/min/1.73 m², or dialysis dependence. Status epilepticus or active convulsions. Cervical spinal cord injury, other spinal cord injury, major chest wall deformity, myasthenia, or respiratory dysfunction primarily caused by brainstem injury. Severe psychiatric or pre-existing neurological or cognitive disorders that would interfere with study evaluation or completion, including amyotrophic lateral sclerosis, dementia, Parkinson disease, Huntington disease, or another clinically significant central nervous system disorder unrelated to the index brain injury. Expected survival of 72 hours or less, or a decision to withhold endotracheal intubation, cardiopulmonary resuscitation, or other life-sustaining treatment. Pregnancy or breastfeeding. Any other condition that, in the investigator's judgment, may place the participant at unacceptable risk or interfere with completion of the study.
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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
3 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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Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000, China
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The 904th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
Suzhu, Jiangsu, 215000, China
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Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Zapping the spine while wearing a robotic ankle: a new way to help kids walk?
- Can a web program rebuild memory after brain injury?
- Can a nurse and a neighbor help tame chronic disease?
- Can PET scans reveal hidden heart inflammation after a stroke?