A personalised radiosurgery procedure for PwTN and PwMSTN (PROMOTION)

  • Research type

    Research Study

  • Full title

    A personalised radiosurgery procedure for people with trigeminal neuralgia\nto improve pain, quality of life and reduce complications – a confidence in concept pilot study (PROMOTION)

  • IRAS ID

    255351

  • Contact name

    Jianhua Wu

  • Contact email

    j.h.wu@leeds.ac.uk

  • Sponsor organisation

    University of Leeds

  • Duration of Study in the UK

    0 years, 11 months, 30 days

  • Research summary

    Trigeminal neuralgia (TN) is a condition of excruciating facial pain characterised by brief, repeated, electric shock-like pains. Like idiopathic TN, people with multiple sclerosis (MS) related TN (PwMSTN) often suffer from episodic facial pain (often excruciating) that may be related to demyelination of the trigeminal pathways. It is estimated that people with multiple sclerosis (PwMS) are 20 times more likely to present with TN symptoms than non-MS people and a recent review estimated that 4-8% of PwMS have TN. Patients with TN or MS-related TN who no longer respond to treatment often opt for non-invasive gamma knife radiosurgery (GKRS), with variable outcomes. Factors, such as patient characteristics, target treatment location and radiation dosage, could affect the efficacy of pain relief and result in post-surgical morbidity. There is no consensus of the best GKRS target treatment location or the optimal radiation dosage for GKRS treatment among centres, this results in great variability across centres in patient outcomes of pain control and morbidity. \nThis prospective surgical pilot study will recruit PwTN and PwMS-related TN from the National Centre for Stereotactic Radiosurgery, Sheffield, to evaluate the impact of a personalised GKRS treatment protocol on safety, efficacy (pain control) and morbidity. The personalised procedure will target the treatment location on trigeminal nerve further away from the brain stem as compared to the current standard treatment location that is closer to the brain stem. The personalised procedure may reduce the radiation dose to the brain stem and then reduce the adverse effects of the treatment. The recruited PwTN and PwMS-related TN will be randomly allocated to either the personalised GKRS treatment protocol group or the standard GKRS treatment protocol group. The efficacy in pain relief and morbidity will be evaluated between the treatment groups at 6 months and 12 months post-surgery.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference

    19/YH/0273

  • Date of REC Opinion

    29 Aug 2019

  • REC opinion

    Favourable Opinion