The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury

Technology
Arm/hand function
Online since 5 November 2021, updated 925 days ago

About this trial

This study is recruiting individuals with chronic cervical (neck area) spinal cord injuries to assess the safety and effect of skin-surface (transcutaneous) spinal cord stimulation on upper extremity (arm, hand, finger) function. Spinal cord stimulation is a technique using electrodes to activate spinal cord nerve networks. This intervention (called ARC Therapy) uses a wearable stimulator unit and skin electrodes attached at the neck region, thus targeting improved upper extremity function. If included in the study, participants will undergo a two-month conventional functional task practice (FTP) program without stimulation, followed by a two-month program of FTP with stimulation. Final testing of upper extremity strength and function will be performed after about 16 months.

Included participants

Gender
All
Age
22 - 75 years
Injury level
C2 - C8
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    12 months - 75 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C2-C8
    Additionally, participants must
    NOT require ventilator support
    NOT have implanted device, e.g. pacemaker
    NOT have severe autonomic dysreflexia

    What’s involved

    Type

    Technology

    Details

    Up to 20 in-clinic training sessions per month Guided, in-clinic conventional functional task practice (FTP) program lasting approximately two months Combined functional task practice and spinal cord stimulation for approximately two months Testing of upper extremity function

    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
    • 8 Jan 2021
    • Organisation
    • ONWARD Medical, Inc.
    • Trial recruitment status
    • Ended
    • Trial start date
    • 8 Jan 2021
    • Organisation
    • ONWARD Medical, Inc.

    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