Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Technology
General health
Online since 3 April 2022, updated 688 days ago

About this trial

This is a trial to test the safety and effect of spinal cord stimulation (SCS) on breathing among individuals with cervical (neck area) spinal cord injuries who need a ventilator to breathe. In this study, stimulation is provided by an electrode implanted next to the spinal cord. If included, participants will first receive respiratory training. Next, participants will receive an implant of the SCS device and 10 days of respiratory rehabilitation using different SCS settings. Stimulation sessions will occur two times per week over 21 months. Final testing, including various measures of breathing function will be performed after 2.5 years.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C2 - C7
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    1 year - 75 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C2-C7
    Additionally, participants must
    be ventilator-dependent with less than 5 cn H20 maximal inspiratory and expiration pressure
    NOT have received lung surgery or intrinsic lung disease

    What’s involved

    Type

    Technology

    Details

    - assessments before and after respiratory training - surgery for implantation of the stimulation electrodes - 10 days of post-surgery respiratory rehabilitation - 2 times per week stimulation sessions for 21 months - follow-up assessments over 2.5 years

    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
    • Trial start date
    • 27 Sep 2021
    • Organisation
    • University of California, Los Angeles
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 27 Sep 2021
    • Organisation
    • University of California, Los Angeles

    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