Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury

This study is looking for adults aged 18-70 with chronic (long-term) incomplete spinal cord injury (SCI) at or below C-3 to T-8. The goal is to improve breathing by strengthening respiratory muscles. Researchers are testing if combining two non-invasive interventions – acute intermittent hypercapnic-hypoxia (brief periods of breathing air with lower oxygen and higher carbon dioxide) and transcutaneous spinal cord stimulation (tSCS, a gentle electrical stimulation to the spine) – can make breathing exercises more effective. Success will be measured by changes in mouth occlusion pressure (P0.1), which indicates how strong your breathing muscles are. The study aims to enroll 20 participants, but the current recruitment status is unclear.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 20 participants.
What's involved
Participants will undergo respiratory resistance training while receiving either tSCS or sham tSCS, and also receive acute intermittent hypercapnic-hypoxia. The study involves measurements at baseline, 30 minutes after the 4th day of intervention, and 24 hours after the 4th day of intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 hours after the 4th day of intervention.

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NCT07135583

Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury

Recruiting
NAAges 18–70InterventionalTreatment
Thomas Jefferson University
~20 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Active Comparator: Single Intervention 1Active Comparator: Single Intervention 2Respiratory Resistance Exercise

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change in mouth occlusion pressure at 0.1 secs (P0.1)
Measured over Pre- Baseline (Day 1), Post 1(30 minute post day 4 intervention) and Post 2 ( 24 hours post day 4 intervention)
Spinal Cord Injury, Chronic
Spinal Cord Injury Cervical
Spinal Cord Injury Thoracic
Incomplete Spinal Cord Injury
1 sites across 1 states
Pennsylvania1
  • Jay Nair, PT, PhD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University

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Eligibility criteria

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.
  • change in mouth occlusion pressure at 0.1 secs (P0.1)Pre- Baseline (Day 1), Post 1(30 minute post day 4 intervention) and Post 2 ( 24 hours post day 4 intervention)

    It measures the pressure generated at the mouth in the first 0.1 second of inspiration when the airway is unexpectedly occluded at the end of expiration. The negative pressure generation in 0.1 seconds reflects respiratory motor drive without time for modification by sensory systems such as lung stretch or visual input. The inspiratory valve will be occluded prior to the onset of inspiration, without participant awareness, and maintained until the subsequent inspiratory effort. Negative pressure generation will be recorded using a pressure transducer connected to a non-rebreathable mask. All respiratory assessments will be performed in accordance with standard testing guidelines. Measurement indices of ventilation will be obtained using a mouthpiece attached to the pneumotach and nasal clips. The mouth pressure from the pneumotach will be converted to a digital signal using Powerlab C.