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NCT07626931

Abdominal Stimulation to Improve Cough After Spinal Cord Injury

Sponsor: Liberate Medical

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if abdominal functional electrical stimulation (FES) using the VentFree Respiratory Muscle Stimulator improves cough strength in adults with a new spinal cord injury (SCI). It will also learn about the safety of abdominal FES in this population. The main questions it aims to answer are: Does abdominal FES improve cough peak flow (a measure of cough strength) compared to cough training alone? Does abdominal FES reduce the number of respiratory complications (such as pneumonia or atelectasis)? What medical problems do participants have when receiving abdominal FES? Researchers will compare abdominal FES (active treatment) to supervised cough training without stimulation (control) to see if abdominal FES improves cough function after spinal cord injury. Participants will: Receive abdominal FES or perform supervised cough training 5 days per week for up to 6 weeks during inpatient rehabilitation Have cough strength and breathing function measured at the start of the study and every week during treatment Complete quality of life and bowel function questionnaires at multiple time points Have a follow-up visit or phone call 4 weeks after completing treatment

Official title: Abdominal Function Electrical Stimulation to Improve Cough Peak Flow After Spinal Cord Injury: A Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-08

Completion Date

2028-06

Last Updated

2026-06-04

Healthy Volunteers

Conditions

Spinal Cord Injuries (SCI)Respiratory Insufficiency

Interventions

DEVICE

Respiratory Muscle Stimulator

Transcutaneous neuromuscular electrical stimulation (NMES) device that applies abdominal functional electrical stimulation (FES) to the abdominal wall muscles in synchrony with the expiratory phase of breathing. The device consists of a control unit, nasal-oral cannula (used to detect breathing phase), disposable transcutaneous stimulation electrodes, and power supply. Electrodes are placed posterolaterally to activate the transversus abdominis and internal and external oblique muscles. Stimulation parameters are 30 Hz / 350 µs during quiet breathing and 50 Hz / 400 µs during coughing. Stimulation amplitude is titrated per session to achieve a strong visible abdominal wall contraction without discomfort, expected to be between 50 mA and 100 mA. Stimulation electrodes and nasal-oral cannula are replaced every five days of treatment.

BEHAVIORAL

Supervised Cough Training

Supervised volitional cough training performed without any active stimulation or device assistance. Participants perform 3 sets of 10 coughs per day with approximately 7 seconds between each cough and 3 to 5 minutes between sets, delivered by a trained research team member at the participant's bedside with the participant sitting upright.

Inclusion Criteria: 1. Adults (≥ 22 years of age) admitted to rehabilitation with a new SCI. 2. New non-progressive SCI occurring in the past 3 to 8 weeks. 3. Neurological level of injury of C1-T5. 4. American Spinal Injuries Association Impairment Scale A to C. 5. CPF of \<160 L/min (Note: A CPF of \<270 L/min has been shown to be associated with decreased secretion clearance and increased respiratory complications, while a CPF of \<160 L/min has been shown to lead to an ineffective cough). 6. Not dependent on mechanical ventilation (people dependent on mechanical ventilation are at greatly increased risk of respiratory complications and are excluded due to this heterogeneity). 7. Able to sit upright. 8. Expected to remain in rehabilitation for at least another 3 weeks. Exclusion Criteria: 1. Respiratory complications in previous 24 hours (screening out iatrogenic complications). 2. Chronic respiratory disease. 3. No contraction of the abdominal wall muscles in response to abdominal NMES. 4. Open abdominal surgery ≤ 4 weeks prior to enrollment. 5. Have yet to undergo spinal surgery to stabilize injury, where required. 6. Body mass index \>40 kg/m2. 7. Pacemaker (external or internal) or implanted electronic device (e.g., a defibrillator). 8. Known or expected to be pregnant. 9. Placed on a palliative/supportive care only pathway. 10. Receiving any of the following as standard of care: * Abdominal FES * Inspiratory or Expiratory muscle training * Transcutaneous or implanted thoracolumbar spinal stimulation 11. Participating in any of the following: * A study with the same or similar primary endpoint * A study investigating electrical stimulation or respiratory muscle therapy * Any study in which the investigator determines may interfere with the results of this study 12. Unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits including facial or dental trauma. 13. Any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results. 14. Unable to provide informed consent. 15. Unwilling to provide informed consent.