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
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