Status:
TERMINATED
Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury
Lead Sponsor:
Thomas Jefferson University
Conditions:
Cervical Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
The objective of this proposal is to test the precision and effectiveness of combining application of AIHH exposure with tSCS to prime response to task specific training in chronic SCI, by pursuing th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06101199
Start Date
October 16 2023
End Date
June 30 2025
Last Update
August 17 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107