Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord

Technology
Arm/hand function
Online since 19 February 2024, updated 51 days ago

About this trial

The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training. This is an investigational study. The device used for epidural spinal stimu...

Included participants

Gender
All
Age
22 - 70 years
Injury level
C1 - T1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    6 months - 20 years
    Healthy volunteers
    Yes
    C1-T1
    Additionally, participants must
    NOT have an intrathecal baclofen pump
    NOT have a history of neuromuscular conditions

    What’s involved

    Type

    Technology

    Details

    It has been demonstrated that electrical stimulation of the spinal cord can activate neural networks located below the site of spinal cord injury (SCI). Particularly, when combined with motor rehabilitation, the use of epidural spinal stimulation (ESS) at the lumbar spinal cord level has shown promise in promoting the recovery of lower limb motor function and enhancing overall well-being. In this project, the investigators propose a feasibility study to investigate the effectiveness of cervical ESS as a therapeutic approach for regaining upper limb (UL) sensorimotor function after SCI. Following the initial Week 1 Clinical examination and screening, Week 2 will involve implanting ESS electrodes with externalized leads into twelve participants (as per the Schema). After implantation in Week 3, participants will undergo a recovery phase. In Week 4, our objectives encompass: 1) characterizing sensorimotor network responses to ESS (electrophysiological assessment), 2) quantifying brain activation and functional connectivity during ESS (neuroimaging assessment), and 3) evaluating upper limb sensorimotor function with ESS (functional assessment). Weeks 5 and 6 introduce combined therapies for upper limb and trunk sensorimotor functions alongside cervical ESS. Week 7 mirrors Week 4 assessments, stratifying participants based on ESS responses into responders and non-responders; non-responders undergo ESS electrode removal, while responders receive permanent impulse pulse generator (IPG) implantation. The investigators anticipate that at least half, if not all, of the 12 participants will respond to ESS therapy and receive the IPG implant. Weeks 8 and 9 entail rest and repeated Clinical examinations. In Week 10, assessments occur with ESS active for only 30 seconds (Sham stimulation), continuing Weeks 11 and 12. Week 13 repeats assessments, followed by Weeks 14 and 15 refining ESS parameters for functional movements. The timeline culminates in a Week 16 post-intervention Clinical examination.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Sensory function

    Standing/walking/mobility

    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 soon
    • Trial start date
    • 1 Mar 2024
    • Organisation
    • The Methodist Hospital Research Institute
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Mar 2024
    • Organisation
    • The Methodist Hospital 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