Brain InjuriesBREATHNCT07766681
Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury
A study testing Epidural Electrode Implantation in people with Brain Injuries and Respiratory Failure, run by Zhongda Hospital at 3 sites in China.
Trial summary
Patients with severe brain injury may develop impaired respiratory drive, diaphragm dysfunction, prolonged mechanical ventilation, and difficulty recovering spontaneous breathing. Epidural spinal cord stimulation may activate preserved spinal respiratory circuits and improve respiratory muscle activity. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Brain Injuries, Respiratory Failure
- What is being tested?
- Epidural Electrode Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesChina
- Study dates
- 5 Aug 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Xiaoyu Xia, Dr. PhD., jiaxy02@163.com
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Fei Peng, Dr. PhD., 15950565786, afei0312@163.com
Fei Peng, Dr.PhD.
The 904th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
Suzhu, Jiangsu, 215000
About this study
Official title: An Exploratory Clinical Trial of Epidural Spinal Cord Stimulation for Respiratory Recovery in Patients With Brain Injury
Patients with severe brain injury may develop impaired respiratory drive, diaphragm dysfunction, prolonged mechanical ventilation, and difficulty recovering spontaneous breathing. Epidural spinal cord stimulation may activate preserved spinal respiratory circuits and improve respiratory muscle activity. This prospective, single-center, non-randomized, single-arm exploratory study will enroll 10 patients with stroke or traumatic brain injury who have impaired consciousness and require invasive mechanical ventilation. Participants will undergo epidural spinal cord stimulation in addition to standard clinical care. Diaphragmatic electrical activity, respiratory function, diaphragm ultrasound findings, diaphragm electromyography, duration of mechanical ventilation, pulmonary infection, length of stay, mortality, safety events, and 6-month neurological outcome will be assessed. The study aims to evaluate the safety and preliminary efficacy of epidural spinal cord stimulation for improving respiratory function after brain injury.
Read the detailed description
Severe central nervous system injury, including stroke and traumatic brain injury, may impair respiratory drive and disrupt descending pathways between brainstem respiratory centers and spinal respiratory motor networks. This can lead to diaphragm weakness, ineffective cough, secretion retention, prolonged mechanical ventilation, pulmonary infection, and difficulty with ventilator liberation.
Epidural spinal cord stimulation is a neuromodulation approach that may increase the excitability of preserved spinal neural circuits and facilitate respiratory motor output. Preclinical and early clinical evidence suggests that spinal stimulation can enhance respiratory muscle activation and improve ventilatory performance.
This study is a prospective, single-center, interventional, non-randomized, single-arm exploratory trial. Ten adults with imaging-confirmed stroke or traumatic brain injury, a Glasgow Coma Scale score of 3 to 8, and a requirement for invasive mechanical ventilation for at least 24 hours will be enrolled. All participants will undergo epidural spinal cord stimulation in addition to standard treatment. Respiratory physiological measurements will be obtained before and after stimulation. Participants will be followed until hospital discharge and subsequently assessed for survival and neurological outcome at 6 months after injury.
The study will evaluate changes in diaphragmatic electrical activity and other respiratory parameters, as well as pulmonary infection, duration of mechanical ventilation, intensive care unit and hospital length of stay, in-hospital mortality, neurological outcome, and intervention-related adverse events.
- Conditions
- Brain Injuries, Respiratory Failure
- Being tested
- Epidural Electrode Implantation
- Keywords
- Epidural spinal cord stimulation, Respiratory failure, Diaphragmatic electrical activity
- Medical subject headings
- Brain Injuries, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Electrode ImplantationProcedure or surgery
Participants will undergo surgical implantation of an epidural spinal cord stimulation electrode under anesthesia. The electrode will be positioned at the spinal level specified in the final surgical protocol and connected to a stimulation system.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Spinal Cord Stimulation | Experimental | Participants will receive epidural spinal cord stimulation in addition to standard neurosurgical, neurocritical care, mechanical ventilation, airway management, and rehabilitation treatment. Respiratory physiological measurements will be obtained before and after stimulation. Receives: Procedure: Epidural Electrode Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Electrical Activity of the Diaphragm From Before to After Spinal Cord Stimulation
Peak electrical activity of the diaphragm will be measured using an electrical activity of the diaphragm catheter. The change from the pre-stimulation value to the post-stimulation value will be reported in microvolts (μV).
Measured: Immediately before stimulation and within 1 hour after stimulation, upto 30 days
Change in Diaphragmatic Electrical Activity Frequency From Before to After Spinal Cord Stimulation
The frequency of diaphragmatic electrical activity signals will be measured using an electrical activity of the diaphragm catheter. The change from before to after stimulation will be reported as events per minute.
Measured: Immediately before stimulation and within 1 hour after stimulation, upto 30 days
Secondary outcomes (11)
Change in the Frequency of Diaphragmatic Electrical Activity Signals With Peak Amplitude of at Least 3 μV
The number of diaphragmatic electrical activity signals with a peak amplitude of at least 3 μV will be determined using an electrical activity of the diaphragm catheter. The change from before to after stimulation will be reported as events per minute.
Measured: Immediately before stimulation and within 1 hour after stimulation, upto 30 days
Change in the Frequency of Spontaneous Inspiratory Efforts Detected by Diaphragmatic Electrical Activity
Spontaneous inspiratory efforts generated by the participant's neural respiratory drive will be detected using an electrical activity of the diaphragm catheter. Ventilator-delivered breaths without a corresponding diaphragmatic electrical activity signal will not be counted. The change from before to after stimulation will be reported as inspiratory efforts per minute.
Measured: Immediately before stimulation and within 1 hour after stimulation, upto 30 days
Spontaneous Respiratory Rate
The participant's spontaneous respiratory rate will be determined from respiratory monitoring and reported as breaths per minute. Ventilator-mandated breaths will be excluded.
Measured: Immediately before stimulation and within 1 hour after stimulation, upto 30 days
Change in Tidal Volume From Before to After Spinal Cord Stimulation
Tidal volume will be measured using the mechanical ventilator under standardized ventilator settings and reported in milliliters (mL).
Measured: Immediately before stimulation and within 1 hour after stimulation, upto 30 days
Diaphragmatic Excursion
Diaphragmatic excursion will be measured by bedside M-mode ultrasonography with the participant in the supine position. Values will be reported in millimeters (mm).
Measured: Immediately before stimulation and within 1 hour after stimulation upto 30 days
Diaphragm Thickening Fraction
Diaphragm thickening fraction will be calculated from inspiratory and expiratory diaphragm thickness measured by bedside ultrasonography and reported as a percentage.
Measured: Immediately before stimulation and within 1 hour after stimulation upto 30 days
Duration of Mechanical Ventilation
Cumulative duration of invasive mechanical ventilation from enrollment until successful liberation from mechanical ventilation, hospital discharge, or death, whichever occurs first. Values will be reported in hours.
Measured: From enrollment through hospital discharge, up to 6 months
ICU Length of Stay
Time from enrollment or intensive care unit admission to intensive care unit discharge or death, reported in hours.
Measured: From enrollment through intensive care unit discharge, up to 6 months
Hospital Length of Stay
Time from hospital admission to hospital discharge or in-hospital death, reported in hours.
Measured: From hospital admission through hospital discharge, up to 6 months
In-Hospital Mortality
Number and percentage of participants who die before hospital discharge.
Measured: From enrollment through hospital discharge, up to 6 months
Adverse Events Related to the Procedure or Device
Number and percentage of participants experiencing adverse events considered possibly, probably, or definitely related to epidural electrode implantation or spinal cord stimulation, including infection, bleeding or hematoma, cerebrospinal fluid leakage, neurological injury, device malfunction, stimulation-related discomfort, or other complications.
Measured: From implantation through the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start5 Aug 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The 904th Hospital of the People's Liberation Army of China, Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Chinese PLA General Hospital
- Responsible party
- Principal investigator, Fei Peng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766681
- Sponsor's protocol ID
- 20260220CSC
- Acronym
- BREATH
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No