Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury
Key facts
- Who runs it
- Thomas Jefferson University
- Where
- Philadelphia, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 4 people enrolled
- Started
- 16 Oct 2023
- Ended
- 30 Jun 2025
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Acute Intermittent Hypercapnic Hypoxia
- Transcutaneous spinal cord stimulation
- SHAM Acute Intermittent Hypercapnic Hypoxia
- SHAM Transcutaneous spinal cord stimulation
- Record updated
- 17 August 2025
- Why it 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
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- Concurrent participation in another drug or device trial that may interfere with this study
- Has uncontrolled cardiopulmonary disease or cardiac symptoms based on medical records and/or abnormal response to intervention
- 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 any active implanted medical device, such as cardiac pacemaker
- Has diffuse lower motor neuron injury rendering majority of muscles not excitable
- 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 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
- 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 in United States
- Thomas Jefferson UniversityPhiladelphia, United States
About the trial
What the trial wants to find out
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.
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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.
The 4 groups in the trial
- AIHH + tSCS-paired Strength TrainingExisting treatment, for comparison
Participants will receive exposure to AIHH followed by transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.
Treatment: Acute Intermittent Hypercapnic Hypoxia and Transcutaneous spinal cord stimulation
- SHAM AIHH + tSCS-paired Strength TrainingTreatment being tested
Participants will receive exposure to SHAM AIHH followed by transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.
Treatment: Transcutaneous spinal cord stimulation and SHAM Acute Intermittent Hypercapnic Hypoxia
- SHAM AIHH + SHAM tSCS-paired Strength TrainingSham treatment, for comparison
Participants will receive exposure to SHAM AIHH followed by SHAM transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.
Treatment: SHAM Acute Intermittent Hypercapnic Hypoxia and SHAM Transcutaneous spinal cord stimulation
- AIHH + SHAM tSCS-paired Strength TrainingTreatment being tested
Participants will receive exposure to AIHH followed by SHAM transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.
Treatment: Acute Intermittent Hypercapnic Hypoxia and SHAM Transcutaneous spinal cord stimulation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Single Session Combined Acute Intermittent Hypercapnic-Hypoxia and Transcutaneous Spinal Stimulation on Cervical Neural Drive in Chronic Spinal Cord Injury
- Record updated
- 17 August 2025