Pairing Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Promote Arm Use After Cervical SCI

Technology
Arm/hand function
Online since 5 November 2021, updated 959 days ago

About this trial

This is a clinical trial to test the combined effect of a breathing intervention combined with spinal cord electrical stimulation on individuals with incomplete cervical (neck area) spinal cord injury. The study will apply acute intermittent hypoxia (AIH), a technique wherein participants repeatedly breath air with low oxygen content for brief periods, alternating with breathing room air with normal oxygen content. AIH will be combined with spinal cord stimulation, using electrodes applied to the skin of the back to activate spinal cord nerve networks. There is some evidence that either intervention applied separately may improve recovery of motor function following SCI, so this study wants to see whether combining the two is beneficial for recovery of hand function. If selected, participants will undergo spinal cord stimulation along with one of two study arms 1) either sham AIH (room air — participants use a breathing mask and do not know their oxygen level); or 2) active AIH. Functional task practice with the hands is included. A total of 24 session (4 days/week) will be performed, with evaluations of arm and hand function at the end of each treatment week. Final testing will be performed at 8 weeks from study initiation.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C3 - C7
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    1 year - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C3-C7
    Additionally, participants must
    NOT be dependent on a ventilator
    NOT have implanted device, e.g. pacemaker or stimulator

    What’s involved

    Type

    Technology

    Details

    Spinal cord stimulation: Electrical stimulation via surface electrodes attached to the skin at the neck region Functional task practice: Progressive upper extremity motor training Intermittent hypoxia: Breathing air with low oxygen content through a face mask A total of 24 sessions (45 minutes each) will be performed over the span of 3 weeks

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Mechanism of action

    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
    • Ended
    • Trial start date
    • 3 Mar 2021
    • Organisation
    • Spaulding Rehabilitation Hospital
    • Trial recruitment status
    • Ended
    • Trial start date
    • 3 Mar 2021
    • Organisation
    • Spaulding Rehabilitation 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