NUTRA-TBI

  • Research type

    Research Study

  • Full title

    Nutritional Treatment for Amelioration of Traumatic Brain Injury

  • IRAS ID

    273132

  • Contact name

    Chris Uff

  • Contact email

    cuff@nhs.net

  • Sponsor organisation

    Queen Mary University of London

  • Clinicaltrials.gov Identifier

    NCT04418440

  • Duration of Study in the UK

    0 years, 6 months, 0 days

  • Research summary

    Traumatic brain injury is a devastating condition with incidence levels representing a global epidemic. Due to the heterogenous and complex nature of the condition, progress in its management has progressed slowly.

    The brain has enormous capacity for recovery and adaptation but often the outcomes are poor. The underlying principal behind the recovery process is the recognition that the brain and spinal cord are able to change over time, by creating new connections between neurones, and thereby restoring function that may have been lost through injury or insult. This process is called neuroplasticity. Whilst there is clearly a great deal of potential for the brain to recover after injury, all too often the actual outcomes are disappointing. The process of neuroplasticity most likely requires support in order for potential gains to be fully realized.

    Our study aims to explore a potential new approach to augment this process. Research from our department and others has identified in animal models the potential for a specific multi-nutrient supplement (Souvenaid®) to improve the growth of new neural connections following injury to the central nervous system and improve the clinical recovery. This particular supplement is already commercially available as an over-the-counter daily drink, and is currently used in the early stages of Alzheimer's Disease to slow cognitive decline. It provides the essential molecular building blocks required for neurons to create new connections between each other and thereby improve connectivity in the brain.

    We aim to identify adult inpatients suffering from acute traumatic brain injury and provide one group with this daily nutritional supplement whilst comparing their outcomes with a control group given routine care. We aim to look for improvements to brain connectivity, cognition and peripheral biomarkers.
    Our primary aim will be to assess the feasibility of a larger and more focused trial in this patient population group.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference

    21/LO/0145

  • Date of REC Opinion

    2 Mar 2021

  • REC opinion

    Unfavourable Opinion