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

NANot yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 18, 2025

Primary Completion Date

August 15, 2027

Study Completion Date

August 15, 2027

Conditions
Spinal Cord Injury, ChronicSpinal Cord Injury CervicalSpinal Cord Injury ThoracicIncomplete Spinal Cord Injury
Interventions
OTHER

Active Comparator: Single Intervention 1

Acute intermittent hypercapnic-hypoxia (15 episodes of 1.5 minute O2= 9%, CO2=4% and balance N2, interspaced with 1.5 min room air

OTHER

Active Comparator: Single Intervention 2

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.

BEHAVIORAL

Respiratory Resistance Exercise

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.

Trial Locations (1)

19107

Thomas Jefferson University Center City Campus, Philadelphia

All Listed Sponsors
lead

Thomas Jefferson University

OTHER

NCT07135583 - Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury | Biotech Hunter | Biotech Hunter