Improving breathing and hand function in spinal cord injury using a special air mixture and electrical stimulation
Effect of Single Session Combined Acute Intermittent Hypercapnic-Hypoxia and Transcutaneous Spinal Stimulation on Cervical Neural Drive in Chronic Spinal Cord Injury
This study is testing if breathing a special air mixture along with electrical stimulation can help people with cervical spinal cord injuries improve their breathing and hand function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06101199 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a therapeutic air mixture known as acute intermittent hypercapnic-hypoxia (AIHH) combined with non-invasive electrical stimulation of the spinal cord and targeted exercise training in individuals with cervical spinal cord injuries. Participants will undergo a series of sessions where they will breathe this specialized air mixture followed by electrical stimulation to enhance muscle strength related to breathing and hand function. The study will assess whether this combined approach can lead to improved motor output and functional abilities in patients with paralysis due to spinal cord injury.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with non-progressive cervical spinal cord injuries who have significant impairment in respiratory function.
Not a fit: Patients with uncontrolled cardiopulmonary diseases or those with lower motor neuron injuries affecting muscle excitability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance respiratory and upper extremity function in patients with spinal cord injuries.
How similar studies have performed: While the specific combination of AIHH and electrical stimulation is novel, similar approaches have shown promise in enhancing motor function in spinal cord injury patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female age 18-65 years old 113 * Non-progressive or central cord spinal cord injury from C2-T1 inclusive * American Spinal Injury Association (ASIA) Impairment Scale or AIS classification B, C, or D * \>20% impairment in maximal inspiratory or expiratory pressure generation, relative to established normative values. * Able to participate in physical and occupational therapy rehabilitation programs * Minimum 12 months post SCI * Capable of providing informed consent * Has adequate caregiver support to facilitate participation in study * Willingness to undergo non-deidentifiable audio and/or visual recording Exclusion Criteria: * Has uncontrolled cardiopulmonary disease or cardiac symptoms based on medical records and/or abnormal response to intervention * Has diffuse lower motor neuron injury rendering majority of muscles not excitable * Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations (neuropathic pain, depression, mood disorders, cognitive disorders, etc.) * Has autonomic dysreflexia that is severe, unstable, or uncontrolled * Has uncontrolled orthostatic hypotension that may interfere with rehabilitation * Requires ventilator support * Has spasms that limit participation in study training as determined by the medical record and/or abnormal response to experimental treatment intervention * Has skin breakdown in areas that will come in contact with electrodes or pressure injuries that prevent participation in physical functioning activities * Has any active implanted medical device, such as cardiac pacemaker * Has no EMG activity, observed via surface e-stim, in phrenic nerve nor at least three (3) hand/forearm muscles * Pregnant, planning to become pregnant, or currently breastfeeding * Concurrent participation in another drug or device trial that may interfere with this study * Has other traumatic injuries, such as peripheral nerve injuries, sever musculoskeletal injuries (e.g., shattered pelvis, long bone fractures) that prevent evaluation of response to or participation in rehabilitation * Non-English speaker
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Jayakrishnan Nair, PT, MSPT, PhD
- Email: Jayakrishnan.Nair@jefferson.edu
- Phone: 352-871-5888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.