The Study of a Neural Interface and a Neurostimulation in the Rehabilitation of Upper Limb Movement Impairments.

Technology
Arm/hand function
Online since 22 September 2022, updated 68 days ago

About this trial

This trial is enrolling individuals with chronic cervical spinal cord injuries to test the effect of a brain-computer interface device that decodes brain activity to control a robotic device. In this study, participants are trained to use thoughts to command a robotic arm orthosis; this moves the arm and performs life-like tasks in a virtual-reality display. Skin-surface electrical stimulation is also applied either during or before the upper limb orthotic use to activate the spinal cord and/or muscles of the paralyzed arm. The goal is to improve arm mobility. If included, participants will train with the robotic arm over 12 rehabilitation sessions. Optionally, participants may undergo blood tests to investigate lipid levels to measure the effectiveness of the rehabilitation methods. Final testing will be performed after 6 weeks.

Included participants

Gender
All
Age
18 - 60 years
Injury level
C3 - C7
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 1 month
  • Injury type
  • Traumatic

    Healthy volunteers
    Yes
    C3-C7
    Additionally, participants must
    NOT have severe cognitive impairments
    NOT have a concomitant disease which has resulted in decrease in muscle strength or increase in muscle tone
    NOT have a significant loss of joint range of motion

    What’s involved

    Type

    Technology

    Details

    Participants will receive a non-invasive rehabilitation technology consisting of surface electrodes applied to the scalp, the arm and the neck. Participants will undergo up to 12 rehabilitation sessions with movement intentions, virtual reality feedback and electrical stimulation as the neck and arm regions. Participants additionally might undergo three blood tests.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Sensory function

    Spasticity

    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

    • Recruitment
    • Unknown
    • Trial start date
    • 1 Oct 2021
    • Organisation
    • Skolkovo Institute of Science and Technology
    • Recruitment
    • Unknown
    • Trial start date
    • 1 Oct 2021
    • Organisation
    • Skolkovo Institute of Science and Technology

    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