Status:
NOT_YET_RECRUITING
Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury
Lead Sponsor:
Thomas Jefferson University
Conditions:
Spinal Cord Injury, Chronic
Spinal Cord Injury Cervical
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Spinal cord injuries (SCI) can seriously affect a person's ability to breathe. This happens because the injury can damage the nerves that control the muscles used for breathing. As a result, people wi...
Detailed Description
The overall objectives of this study are: To determine whether combining hypercapnic-hypoxia protocol (HiCO₂-AIH) and transcutaneous spinal cord stimulation (tSCS) can enhance the effects of respirat...
Eligibility Criteria
Inclusion
- adults 18 to 70 years of age (the latter to reduce likelihood of cardiovascular disease);
- chronic SCI for ≥ 1 year at or below C-3 to T-8
- incomplete SCI based on classification of incomplete-B, C or D
- medically stable with clearance from physician
- SCI due to non-progressive etiology
- \>20% impairment in maximal inspiratory or expiratory pressure generation
Exclusion
- Individuals will be excluded due to (1) current diagnosis of an additional neurologic condition (eg. multiple sclerosis or stroke) (2) loss of diaphragm EMG activity on forced respiratory tests; (3) severe illness or infection (4) non-healing decubitus ulcers (5) untreated bladder or urinary infections (6) cardiovascular disease (7) lung disease (8) active heterotopic ossification (9) uncontrolled hypertension; (10) severe neuropathic pain; (11) pregnancy (5) severe recurrent and uncontrolled autonomic dysreflexia (6) history of seizure disorder.
Key Trial Info
Start Date :
August 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07135583
Start Date
August 18 2025
End Date
August 15 2027
Last Update
August 27 2025
Active Locations (1)
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1
Thomas Jefferson University Center City Campus
Philadelphia, Pennsylvania, United States, 19107