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NCT07135583 · ClinicalTrials.gov registry record · NA
Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury
A NA study of Spinal Cord Injury Cervical and Incomplete Spinal Cord Injury, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07135583: Recruiting NA study of Spinal Cord Injury Cervical and Incomplete Spinal Cord Injury, sponsored by Thomas Jefferson University.
NCT07135583 is a NA study of Spinal Cord Injury Cervical and Incomplete Spinal Cord Injury that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 20 participants, roughly in line with the 19-participant average among 12 other Spinal Cord Injury Cervical trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07135583, a NA study of Spinal Cord Injury Cervical and Incomplete Spinal Cord Injury, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 with SCI often face breathing problems, a higher risk of lung infections, and even early death. While breathing exercises can help strengthen these muscles, they often aren't intense enough to make a big difference, especially in people with long-term injuries. This research project is exploring a new way to improve breathing in people with chronic SCI. The goal is to "wake up" the remaining nerve pathways that still connect the brain and spinal cord to the breathing muscles. By doing this, the investigators hope to make breathing exercises more effective and improve overall respiratory health. The investigators are testing a combination of two non-invasive (non-surgical) techniques: Transcutaneous Spinal Cord Stimulation (tSCS): This uses small electrical pulses delivered through the skin to stimulate the spinal cord and help activate the muscles used for breathing. Hypercapnic-Hypoxia Protocol (HiCO₂-AIH): This involves breathing air with lower oxygen and higher carbon dioxide for short periods. This naturally increases the brain's drive to breathe and may help strengthen the breathing muscles. The investigators believe that using these two techniques together will "prime" the nervous system, making it more responsive to breathing exercises. This could lead to better outcomes for people with SCI. In addition to testing this treatment, the investigators are also collecting saliva and blood samples to look for biomarkers-biological clues that might help predict who will benefit most from this therapy. These include genetic markers and signs of nerve damage in the blood. Who Can Participate The investigators are looking for adults aged 18 to 70 who: Have had a spinal cord injury for at least one year. Have an injury between the neck and upper back (from C3 to T8).
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Active Comparator: Single Intervention 1
- OTHER Active Comparator: Single Intervention 2
- BEHAVIORAL Respiratory Resistance Exercise
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Center City Campus - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-09-18 |
| Est. Completion | 2027-08-15 |
| Phase | NA |
What NCT07135583 shows while recruiting
NCT07135583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, roughly in line with the 19-participant average among 12 other Spinal Cord Injury Cervical trials with a reported enrollment target.
The record links to 4 conditions, with Spinal Cord Injury Cervical appearing as the primary indexed condition, and to 3 interventions - of which Active Comparator: Single Intervention 1 is the first listed.
NCT07135583 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07135583 about?
NCT07135583 is a clinical study titled "Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury". 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 with SCI often face breathing problems, a higher risk of lung infections, and even early death. While ...
What is the current status of trial NCT07135583?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-09-18. Estimated completion is 2027-08-15.
What conditions does trial NCT07135583 study?
This clinical trial studies the following conditions: Spinal Cord Injury Cervical, Incomplete Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Injury, Chronic.
What interventions are being tested in trial NCT07135583?
The interventions under investigation include: Active Comparator: Single Intervention 1 (OTHER), Active Comparator: Single Intervention 2 (OTHER), Respiratory Resistance Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT07135583?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07135583 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07135583's enrollment target sits among peer trials
20 4th of 12 higher than 7 of 12 other Spinal Cord Injury Cervical trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury Cervical trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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