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

Pain Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117035
• Other study ID #: 255351
• Secondary ID: 115658
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: University of Leeds
• Contact: Jianhua Wu, PhD
• Phone: 0113 343 3431
• Email: j.h.wu[@]leeds.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuralgia
• Pain
• Sclerosis
• Trigeminal Neuralgia

Intervention

Procedure:
• Gamma Knife Radiosurgery (GKRS) personalised procedure
Personalised GKRS treatment
• GKRS standard care
Standard GKRS treatment

Locations

Country	Name	City	State
United Kingdom	Sheffield royal hallamshire hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barrow Neurological Institute (BNI) pain measure	BNI Pain Scale (BNI-PS), 5-level categories (scale range: 1-5)	6 MONTHS
Primary	Barrow Neurological Institute (BNI) numbness measure	BNI Numbness Scale (BNI-NS), 5-level categories (scale range: 1-5)	6 MONTHS
Secondary	Current medication and dosage		12 MONTHS
Secondary	Vision complications	Recorded as adverse events such as blurred vision, double vision, or water eyes	12 MONTHS
Secondary	Motor impairment	Assessed through a battery of test with a performance score (range: 1-100)	12 MONTHS
Secondary	Cognitive impairment	Assessed through a battery of test with a performance score (range: 1-100)	12 MONTHS