Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Functio… (NCT06101199) | Clinical Trial Compass
TerminatedNot Applicable
Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury
Stopped: The study evolved into a multi day clinical trial and was recently awarded an extramural funding. The new study will begin enrollment in late August 2025
United States4 participantsStarted 2023-10-16
Plain-language summary
The goal of this clinical trial is to determine whether people with paralysis due to a spinal cord injury can benefit from breathing short intermittent bouts of air with low oxygen (O2) combined with slightly higher levels of carbon dioxide (CO2), interspaced by breathing room air. The technical name for this therapeutic air mixture is 'acute intermittent hypercapnic-hypoxia,' abbreviated as AIHH. Following exposure to the gas mixture, participants will receive non-invasive electrical stimulation to the spinal cord paired with specific and targeted exercise training.
The main question this trial aims to answer is: Can the therapeutic application of AIHH, combined with non-invasive electrical stimulation to the spinal cord plus exercise training, increase the strength of muscles involved in breathing and hand function in people with paralysis due to a spinal cord injury?
Participants will be asked to attend a minimum of five study visits, each separated by at least a week. During these visits, participants will be required to:
* Answer basic questions about their health
* Receive exposure to the therapeutic air mixture (AIHH)
* Undergo non-invasive spinal electrical stimulation
* Complete functional breathing and arm strength testing
* Undergo a single blood draw
* Provide a saliva sample
Researchers will compare the results of individuals without a spinal cord injury to those of individuals with a spinal cord injury to determine if the effects are similar.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Respiratory cortical and spinal drive in minutes of intervention
Timeframe: Baseline
2
Change in Upper extremity cortical and spinal drive in minutes of intervention
Timeframe: Baseline
3
Change in Maximum respiratory voluntary force production in minutes of intervention
Timeframe: Baseline
4
Change in Airway occlusion pressure (P0.1) in minutes of intervention
Timeframe: Baseline
5
Change in Forced vital capacity in minutes of intervention
Timeframe: Baseline
6
Change in Upper extremity functional assessment in minutes of intervention