Improving breathing in spinal cord injury patients using stimulation and training

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance respiratory function in patients with spinal cord injuries by combining epidural spinal cord stimulation with a respiratory training protocol. The research focuses on understanding how these interventions can activate and reorganize spinal motor networks responsible for respiration. By investigating the effects of spinal cord stimulation alone and in conjunction with respiratory training, the study seeks to develop a new standard of care for respiratory rehabilitation in this population. The ultimate goal is to reduce morbidity and mortality associated with respiratory complications in individuals with chronic spinal cord injuries.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least 18 years old
* Stable medical condition
* Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI)
* Sustained SCI at least 24 months prior to entering the study
* At least 15%-deficit in pulmonary function outcomes

Exclusion Criteria:

* Painful musculo-skeletal dysfunction
* Unhealed fracture
* Contracture
* Pressure sore
* Urinary tract infection that might interfere with respiratory training
* Clinically significant depression
* Psychiatric disorders
* Ongoing drug abuse;
* Major cardiovascular disease
* Major pulmonary disease
* Ventilator dependence
* Major endocrine disorders
* Malignancy
* Marked obesity
* Deep vein thrombosis
* HIV/AIDS related illness
* Secondary causes of respiratory dysfunction
* Major gastrointestinal problems
* Other major medical illness contraindicated for respiratory training
* Pregnantcy

Where it's running

• Frazier Rehabilitation and Neuroscience Institute
  Louisville, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Alexander Ovechkin, MD, PhD — University of Louisville
• Study coordinator: Alexander Ovechkin, MD, PhD
• Email: avovec02@louisville.edu
• Phone: 5025818675

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.