Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury

NCT07766681 | Not Yet Recruiting

• 1 other identifier: 20260220CSC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Brain Injuries; Respiratory Failure

Keywords

Epidural spinal cord stimulation; Respiratory failure; Diaphragmatic electrical activity

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  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

  Immediately before stimulation and within 1 hour after stimulation, upto 30 days

• Spontaneous Respiratory Rate

  Immediately before stimulation and within 1 hour after stimulation, upto 30 days

• Change in Tidal Volume From Before to After Spinal Cord Stimulation

  Immediately before stimulation and within 1 hour after stimulation, upto 30 days

• Diaphragmatic Excursion

  Immediately before stimulation and within 1 hour after stimulation upto 30 days

Study Arms (1)

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.

Procedure: Epidural Electrode Implantation

Interventions

Epidural Electrode Implantation PROCEDURE

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.

Epidural Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead
• The 904th Hospital of the People's Liberation Army of China: collaborator
• Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences: collaborator
• Chinese PLA General Hospital: collaborator

Study Sites (3)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

Location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

The 904th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army

Suzhu, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Brain Injuries; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Fei Peng, PhD. MD.

CONTACT

15950565786; afei0312@163.com

Yi Li, PhD.

CONTACT

136 6180 0806; liyi@@ion.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 14, 2026
• Study Start: August 5, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)