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NCT06101199 · ClinicalTrials.gov registry record · NA
Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury
A NA study, sponsored by Thomas Jefferson University.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT06101199: Clinical Trial NA study, sponsored by Thomas Jefferson University.
NCT06101199 is a NA study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06101199, a NA study, was terminated before completion, sponsored by Thomas Jefferson University.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study 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 slightly higher levels of carbon dioxide (CO2), interspaced by breathing room air. The technical name for this therapeutic air mixture is 'acute intermittent hypercapnic-hypoxia,' abbreviated as AIHH. Following exposure to the gas mixture, participants will receive non-invasive electrical stimulation to the spinal cord paired with specific and targeted exercise training. The main question this trial aims to answer is: Can the therapeutic application of AIHH, combined with non-invasive electrical stimulation to the spinal cord plus exercise training, increase the strength of muscles involved in breathing and hand function in people with paralysis due to a spinal cord injury? Participants will be asked to attend a minimum of five study visits, each separated by at least a week. During these visits, participants will be required to: * Answer basic questions about their health * Receive exposure to the therapeutic air mixture (AIHH) * Undergo non-invasive spinal electrical stimulation * Complete functional breathing and arm strength testing * Undergo a single blood draw * Provide a saliva sample Researchers will compare the results of individuals without a spinal cord injury to those of individuals with a spinal cord injury to determine if the effects are similar.
Primary Outcome
Transcranial magnetic stimulation (TMS). Subjects will be seated comfortably with the neck slightly flexed. The vertex of the skull is identified by the intersection between nasion to inion and tragus to tragus. The region of the cortex responsible for diaphragm motor activation is located approximately 3 cm lateral and 2 cm anterior to the vertex. Single-pulse (1 Hz) stimuli are delivered using a handheld 70-mm figure-of-eight coil. Cervical Magnetic Stimulation (CMS). Single-pulse (1 Hz) stim
Interventions
- OTHER Transcutaneous spinal cord stimulation
- OTHER Acute Intermittent Hypercapnic Hypoxia
- OTHER SHAM Acute Intermittent Hypercapnic Hypoxia
- OTHER SHAM Transcutaneous spinal cord stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-10-16 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
Why NCT06101199 stopped before completion
NCT06101199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 4 interventions - of which Transcutaneous spinal cord stimulation is the first listed.
NCT06101199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06101199 about?
NCT06101199 is a clinical study titled "Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury". 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 slightly higher levels of carbon dioxide (CO2), interspaced by breathing room air. The technical nam...
What is the current status of trial NCT06101199?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2023-10-16. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT06101199?
The interventions under investigation include: Transcutaneous spinal cord stimulation (OTHER), Acute Intermittent Hypercapnic Hypoxia (OTHER), SHAM Acute Intermittent Hypercapnic Hypoxia (OTHER), SHAM Transcutaneous spinal cord stimulation (OTHER).
Who is sponsoring clinical trial NCT06101199?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06101199's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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