Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury

Description

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.

Conditions

Cervical Spinal Cord Injury

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Study Overview

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Study Details

Study overview

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.

Effect of Single Session Combined Acute Intermittent Hypercapnic-Hypoxia and Transcutaneous Spinal Stimulation on Cervical Neural Drive in Chronic Spinal Cord Injury

Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury

Condition
Cervical Spinal Cord Injury
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Thomas Jefferson University,

Justine Dee, PT, STUDY_CHAIR, Thomas Jefferson University

Study Record Dates

2026-09