Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury

Technology
Arm/hand function
Online since 28 April 2022, updated 751 days ago

About this trial

This is a trial to test the effect of upper limb rehabilitation with a robotic device (InMotion Hand and InMotion Arm robots) after nerve transfer surgery in individuals with a cervical spinal cord injury. Nerve transfer surgery is the connection of a functionally intact nerve to a target nerve attached to a muscle that has significant weakness or paralysis. The main study goal is to test at what time point the robotic rehabilitation has the greatest effect on upper limb function (experimental group: robotic training 1 year after nerve transfer surgery; control group: 1 year after nerve transfer surgery + an additional 6 weeks before robotic training is begun). If included, the participant will receive nerve transfer surgery and undergo 18 sessions of upper limb robotic training, 3 times per week, for 6 weeks at one of 2 different time points after nerve transfer surgery. Clinical neurological, functional or cortical stimulation tests will be conducted before surgery, after surgery and after robotic training. The cortical stimulation is a non-invasive technique which uses transcranial magnetic stimulation (TMS) over the outer surface of the head to activate the central nervous system (CNS) and is applied to test whether there have been changes in neuronal connections within the CNS.

Included participants

Gender
All
Age
18 - 50 years
Injury level
C5 - C7
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    6 months - 50 years
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    No
    C5-C7
    Additionally, participants must
    have a C5, C6, or C7 level spinal cord injury for at least 6 months and have some motor dysfunction in the hand.
    have function in the “donor” nerve to be used in the nerve transfer surgery (usually a nerve innervated by a spinal cord segment above the spinal cord injury level).
    have one of the following ASIA impairment scale (AIS):

    What’s involved

    Type

    Technology

    Details

    Nerve transfer surgery at the Massachusetts General Hospital in Boston, MA will be completed in all participants If assigned to the experimental group, you will receive 18 sessions of upper limb robotic upper limb training (3 times per week, for 6 weeks) with a start time of 1 year after nerve transfer surgery. If assigned to the control group, you will receive upper limb robotic training, but not start until 1 year + 6 weeks after nerve transfer surgery. Clinical neurological assessments, functional examinations and TMS will be performed before nerve transfer surgery, just after surgery, and after robotic upper limb training using one of the 2 different delays after nerve transfer surgery.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Spasticity

    Standing/walking/mobility

    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
    • Recruiting
    • Trial start date
    • 26 Jul 2019
    • Organisation
    • Burke Medical Research Institute
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 26 Jul 2019
    • Organisation
    • Burke Medical Research Institute

    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