Neuro-navigated TMS for Chronic SCI Patients

Technology
General health
Online since 30 December 2023, updated 62 days ago

About this trial

Can neuro-navigated Transcranial Magnetic Stimulation be used as an additional outcome measure to EM-SCI assessments in a Spinal cord injury trial? Compare EM-SCI assessment with nTMS in ten chronic ...

Included participants

Gender
All
Age
All ages
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T12

    What’s involved

    Type

    Observational

    Details

    This is an exciting time for translating experimental Advanced Therapies into treatments for spinal cord injury (SCI). There are currently no regenerative therapies available that target the underlying biology. Over the last 5 years the investigating team have developed a viable gene therapy approach for treating SCI in pre-clinical models. The investigators are on the cusp of translating this therapy to first-in-human studies and are leading a programme to establish a world-first regenerative gene therapy for traumatic SCI affecting upper limb mobility (since recovery of arm/hand function is one of the highest patient priorities). The team will develop an innovative trial design involving neurosurgical delivery of the gene therapy into the spinal cord, followed by specialist neurorehabilitation. For a clinical trial to have the best chance of success, one of the key steps needed to be addressed include validation of new assessment methods for the clinical trial. Our aim is to determine whether neuro-navigated Transcranial Magnetic Stimulation (nTMS) can be used as an adjunct to standard assessments of function in SCI patients. Following two patient and public involvement events (patient focus group and feedback for project design with our rehabilitation partners), the investigating team will recruit chronic SCI subjects to carry out European Multicenter Study about SCI (EM-SCI) assessments. EM-SCI assessments are well established assessment tools for SCI patients and include the EM-SCI 'core' assessments (ISNCSCI, WISCI-III, Walk Test, SCIM 3) and EM-SCI 'additional' assessments (GRASSP, Pain score, neurophysiology). Following this investigators will compare and validate nTMS with EM-SCI assessments in stable chronic SCI patients with both cervical and thoracic injuries. nTMS with combined Tractography MRI of the cortico-spinal tract (the main motor pathway of the spinal cord) will allow functional characterisation and density measurements of this tract in SCI patients.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    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
    • 1 Jul 2023
    • Organisation
    • King's College Hospital NHS Trust
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jul 2023
    • Organisation
    • King's College Hospital NHS Trust

    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