Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury

This is a respiratory rehabilitation-based clinical study consisting of physiologically and functionally relevant mapping of respiratory function that enhances our knowledge of neurophysiological modulation evoked by non-invasive spinal cord Transcutaneous Stimulation (scTS) and contributes to the development of the next generation of rehabilitative approaches. Following the screening process and recruiting, the research subjects will undergo the following procedures: Subjects (total n=36) will be randomly assigned to three groups and will undergo baseline assessments; evaluations before and after 80 sessions of specific intervention (Respiratory Training /RT/ alone, scTS alone, or RT in combination with scTS); and during 16 week-long follow up period.

Inclusion criteria

• At least 18 years old;
• stable medical condition;
• no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with respiratory training or stimulation;
• no clinically significant depression, psychiatric disorders or ongoing drug abuse;
• non-progressive SCI (no negative change in the neurological level and motor-completeness assessed during screening when compared to the neurological status assessed at 6-mo period after injury or at least 6 months prior to the screening), non-ventilator dependence, motor-complete SCI according to the American Spinal Injury Association Impairment Scale (AIS) grade "A" or "B" above T5 spinal level;
• sustained SCI at least 12 months prior to entering the study;
• compared to the normative values for healthy population, at least 15%-deficit in pulmonary function outcomes (FVC and FEV1) as detected by screening spirometry.

Exclusion criteria

Participants will be excluded from the study if there is a presence of

• major pulmonary or cardiovascular disease,
• ventilator dependence,
• endocrine disorders,
• malignancy,
• marked obesity,
• deep vein thrombosis,
• HIV/AIDS-related illness,
• secondary hypotension (anemia, hypervolemia, endocrine and neurological diseases),
• major esophageal/gastrointestinal problem or other major medical illness contraindicated for respiratory training or testing.

During screening, the potential participant will be asked whether she is pregnant or planning to become pregnant during the study period. Pregnant women are excluded from this study, as the risk to the fetus is unknown. No pregnancy test or birth control regimen will be required.