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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07135583
Status
Recruiting
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Conditions

  • Incomplete Spinal Cord Injury
  • Spinal Cord Injury Cervical
  • Spinal Cord Injury Thoracic
  • Spinal Cord Injury, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Comparator: Single Intervention 1 — OTHER
    Acute intermittent hypercapnic-hypoxia (15 episodes of 1.5 minute O2= 9%, CO2=4% and balance N2, interspaced with 1.5 min room air
  • Active Comparator: Single Intervention 2 — OTHER
    An open-loop continuous tSCS stimulation \[30 min duration, low frequency (30 Hz), tolerable intensity (\~10-15 mA), 400 µsec pulse width, biphasic symmetric waveform\] will be delivered using 2 channels: Channel 1- C4-C5 spine; Channel 2- T4 spine; returning electrodes at ASIS.
  • Respiratory Resistance Exercise — BEHAVIORAL
    Respiratory strength training will be conducted using a standard, spring-loaded threshold device while the participant is receiving either tSCS or Sham tSCS. Participants will complete one warm-up set at a pressure threshold approximately 40% of their pre-test outcomes (obtained on day 1 of the corresponding intervention block) for maximal inspiratory and expiratory pressure generation. Following the warm-up, participants will train at a pressure threshold approximately 70% of their pre-test outcomes and will complete three sets of 6-12 repetitions for both inspiratory and expiratory strength training. A training breath will consist of a \~1-2-second sustained effort through the device, separated by 5-10 seconds of quiet breathing. The order of the three sets each of inspiratory or expiratory training will alternate for each of the five daily sessions; the order on day 1 of training will be randomly determined.

Study Details

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). Have an incomplete injury (some nerve function remains). Are medically stable and cleared by a doctor. Have at least a 20% reduction in breathing strength. What Participants Will Do Each participant will complete four rounds of treatment. Each round includes four days in a row of therapy, followed by a three-week break before the next round. Each daily session lasts about two hours and includes: Breathing special air mixtures (low oxygen and high carbon dioxide) for short periods, followed by normal air. A short break. Then, spinal cord stimulation combined with breathing exercises that use resistance (like breathing through a straw). What the Investigators Will Measure The investigators will track: Breathing ability using lung function tests and pressure measurements. Nerve activity using brain and spinal cord stimulation to see how well the diaphragm (the main breathing muscle) responds. Safety by monitoring oxygen levels, heart rate, blood pressure, and breathing responses during each session. Biological Samples Participants will provide: A one-time saliva sample for genetic testing. A one-time blood sample to look for markers of nerve injury. Why This Matters This study could lead to new, non-invasive treatments that improve breathing and quality of life for people living with spinal cord injuries. By identifying who is most likely to benefit from this therapy, the investigators can also move toward more personalized and effective care in the future.

Key Dates

Start date
Sep 18, 2025
Status verified
Oct 2025
Primary completion
Aug 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Combined Intervention
    Experimental Combination of HiCO2-AIH+ tSCS paired respiratory exercise
  • Active Comparator: Single Intervention 1
    Combination of HiCO2-AIH+ Sham stimulation paired respiratory exercise
  • Active Comparator: Single Intervention 2
    Combination of Sham Exposure + tSCS paired respiratory exercise
  • Placebo Comparator: Sham Intervention
    Combination of Sham Exposure + Sham Stimulation paired respiratory exercise

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University Center City CampusPhiladelphiaPennsylvania19107
Jayakrishnan
[email protected]
3528715888

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