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

Drug
General health
Online since 4 September 2025, updated 62 days ago

About this trial

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 wi...

Included participants

Gender
All
Age
18 - 70 years
Injury level
C3 - T8
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 12 months
    Healthy volunteers
    No
    C3-T8

    What’s involved

    Type

    Drug

    Details

    The overall objectives of this study are: To determine whether combining hypercapnic-hypoxia protocol (HiCO₂-AIH) and transcutaneous spinal cord stimulation (tSCS) can enhance the effects of respiratory resistance training in individuals with chronic spinal cord injury (SCI). To explore whether genetic and blood-based biomarkers can help predict how individuals respond to this combined intervention. We will test these objectives in adults with chronic SCI using a Williams cross-over design. The study will include 16 participants (with statistical power \>0.8 and α=0.05), accounting for a 20% dropout rate, for a total enrollment of 20 participants. Specific Aims Aim 1: To determine whether four consecutive days of combined HiCO₂-AIH and tSCS will improve the effectiveness of respiratory resistance training compared to either intervention alone. Outcomes (measured from PRE to 1 day POST intervention): Primary Outcome: Change in mouth occlusion pressure at 0.1 seconds (P0.1). Secondary Outcomes: Maximal inspiratory and expiratory pressure generation, forced vital capacity (FVC), neurophysiological measures of cortico-spinal drive (amplitude of transcranial magnetic stimulation \[TMS\]) and local spinal excitability (amplitude of cervical magnetic stimulation \[CMS\]) in the diaphragm. Safety Outcomes: Continuous monitoring of respiratory parameters (end tidal oxygen \[O₂\] and carbon dioxide \[CO₂\] concentration, oxygen saturation \[SpO₂\]) and cardiovascular parameters (blood pressure \[BP\], heart rate \[HR\], and electrocardiogram \[ECG\]) during each session. Aim 2: To identify predictive factors for treatment response to the combined HiCO₂-AIH and tSCS intervention using: 1. Genetic polymorphisms related to intermittent hypoxia signaling pathways. 2. Molecular markers of neurotrauma and inflammation found in blood extracellular vesicles (EVs). Outcomes: Regression analyses will be conducted to examine the relationship between treatment outcomes and: Specific genetic single nucleotide polymorphisms (SNPs). Blood-based molecular markers of neurotrauma and inflammation.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more


    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 18 Aug 2025
    • Organisation
    • Thomas Jefferson University
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 18 Aug 2025
    • Organisation
    • Thomas Jefferson University

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more