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Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury
NCT07135583 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07135583
The ClinicalTrials.gov registry entry for NCT07135583 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 324 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07135583 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07135583?
This trial is sponsored by Thomas Jefferson University, which has 324 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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