A Personalised Radiosurgery Procedure for People With Trigeminal Neuralgia to Improve Pain, Quality of Life and Reduce Complications

A Personalised Radiosurgery Procedure for People With Trigeminal Neuralgia to Improve Pain, Quality of Life and Reduce Complications - a Confidence in Concept Pilot Study (PROMOTION)

The aim of this study is to evaluate prospectively the feasibility and impact of personalised gamma knife radiosurgery treatment protocol versus current standard protocol for people with idiopathic or Multiple Sclerosis-related Trigeminal Neurolgia (MS related TN) on effectiveness in pain relief, the development of morbidity and quality of life.

Patients with TN or MS-related TN are referred to the National Centre for Stereotactic Radiosurgery in Sheffield for clinical consultation, and will undergo gamma knife radiosurgery (GNRS) for treating trigeminal neuralgia if eligible. The GKRS treatment is provided as a standard National Health Service (NHS) routine care. The current procedure has been proven to be safe and effectiveness in reducing the pain caused by TN. The current GKRS treatment protocol performs the treatment on the trigeminal nerve close to the brainstem, which might result in higher complication rate (mainly facial numbness). This study will conduct a pilot randomised controlled trial to evaluate an alternative treatment protocol, which will perform the GKRS treatment at the retrogasserian zone (further away from the brainstem). This treatment protocol has been widely used in Europe and USA, and is safe and effective. Most studies adopting this protocol have shown less complication rate after treatment.

Study Overview

• Status: Recruiting
• Conditions: Pain; Multiple Sclerosis; Trigeminal Neuralgia
• Intervention / Treatment: Procedure: GKRS standard care; Procedure: Gamma Knife Radiosurgery (GKRS) personalised procedure

Detailed Description

Trigeminal neuralgia (TN) is a condition of excruciating facial pain characterized 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 centers, this results in great variability across centers in patient outcomes of pain control and morbidity. This prospective surgical pilot study will recruit PwTN and PwMS-related TN from the National Center for Stereotactic Radiosurgery, Sheffield, to evaluate the impact of a personalized GKRS treatment protocol on safety, efficacy (pain control) and morbidity. The personalized 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 personalized 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 personalized 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.

This study does not have main ethical, legal issues. The GKRS treatment is provided as routine NHS care, and the study will only alter the treatment location for those patients who would normally go through the standardtreatment protocol. Therefor there will be no management issues.

Information collected during this study will be kept confidential. All data collected for this study will be kept safely and securely on secure NHS computer server and paper records at the clinic. All data will be handled strictly according to the University of Leeds privacy notice for research participants

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianhua Wu, PhD; Phone Number: 0113 343 3431; Email: j.h.wu@leeds.ac.uk
• Study Contact Backup: Name: Sakina Edwebi, PhD; Phone Number: 07825814912; Email: S.Edwebi@leeds.ac.uk

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • Recruiting
    • Sheffield royal hallamshire hospital
    • Contact: Alison Loescher, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject has idiopathic TN or MS-related TN.
2. Subject is available for follow up.

4. Subject can understand the informed consent form in English. 5. Age over 18 years at the time of signing the Informed Consent Form 6. Have been treatment planned to receive GKRS treatment

Exclusion Criteria:

Patients who:

1. Have no capacity to complete written informed consent
2. Do not understand English
3. Repeat GKRS treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Procedure: Gamma Knife Radiosurgery (GKRS) personalised procedure; Personalised GKRS treatment
Placebo Comparator: Control arm; Standard care	Procedure: GKRS standard care; Standard GKRS treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barrow Neurological Institute (BNI) pain measure	BNI Pain Scale (BNI-PS), 5-level categories (scale range: 1-5)	6 MONTHS
Barrow Neurological Institute (BNI) numbness measure	BNI Numbness Scale (BNI-NS), 5-level categories (scale range: 1-5)	6 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current medication and dosage		12 MONTHS
Vision complications	Recorded as adverse events such as blurred vision, double vision, or water eyes	12 MONTHS
Motor impairment	Assessed through a battery of test with a performance score (range: 1-100)	12 MONTHS
Cognitive impairment	Assessed through a battery of test with a performance score (range: 1-100)	12 MONTHS

Collaborators and Investigators

• Sponsor: University of Leeds
• Investigators: Principal Investigator: Jianhua Wu, PhD, University of Leeds

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Quality of life; multiple sclerosis; trigeminal neuralgia
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Multiple Sclerosis; Sclerosis; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: 255351; 115658 (Other Identifier: University of Leeds)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No