Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation

Technology
Standing/walking/mobility
Online since 3 November 2021, updated 888 days ago

About this trial

This trial is enrolling individuals with acute spinal cord injuries (less than 3 weeks) to test the implantation of an illuminating laser fiber into the spinal cord during standard surgical decompression. Previous studies have examined the use of near-infrared light in different diseases and it is used clinically for some disorders. In nerve injury, researchers want to see if light therapy enhances the activity of various enzymes, reduces inflammation, and promotes nerve regeneration. This kind of biostimulation has been widely used in the rehabilitation of nerve injury but not in the spinal cord, where illumination is difficult to reach. If selected for the trial, participants with acute spinal cord injuries will be randomly assigned to one of two study groups: 1) receiving the standard surgical procedure (laminectomy) to remove bone fragments and create space for the spinal cord, or 2) receiving the standard surgical procedure plus the implanting of a spinal nerve laser apparatus (a laser device and 360° scattering medical fiber). After surgery, light stimulation is applied by the implant once a day for 60 minutes. The effect of this stimulation on neurological function will be measured, and compared between the experimental group (laser implant) and the laminectomy only (control) group.

Included participants

Gender
All
Age
20 - 70 years
Injury level
T2 - L1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≤ 3 weeks
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T2-L1
    Additionally, participants must
    require surgical laminectomy
    have a BMI < 40
    NOT have a systemic infection or a local infection at the target surgical site

    What’s involved

    Type

    Technology

    Details

    Standard surgery to remove bone fragments and creating space for the spinal cord Spinal nerve laser apparatus implantation in half of the participants Outcome assessments over 12 months to assess the motor and sensory component of the nervous system

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Sensory function

    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
    • Unknown
    • Trial start date
    • 1 Sep 2018
    • Organisation
    • Xijing Hospital
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Sep 2018
    • Organisation
    • Xijing Hospital

    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