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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04117035
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : September 29, 2021
Information provided by (Responsible Party):
Jianhua Wu, University of Leeds

Brief 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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Multiple Sclerosis Pain Procedure: Gamma Knife Radiosurgery (GKRS) personalised procedure Procedure: GKRS standard care Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-blinded randomised control pilot study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Control arm
Standard care
Procedure: GKRS standard care
Standard GKRS treatment

Experimental: Intervention Procedure: Gamma Knife Radiosurgery (GKRS) personalised procedure
Personalised GKRS treatment

Primary Outcome Measures :
  1. Barrow Neurological Institute (BNI) pain measure [ Time Frame: 6 MONTHS ]
    BNI Pain Scale (BNI-PS), 5-level categories (scale range: 1-5)

  2. Barrow Neurological Institute (BNI) numbness measure [ Time Frame: 6 MONTHS ]
    BNI Numbness Scale (BNI-NS), 5-level categories (scale range: 1-5)

Secondary Outcome Measures :
  1. Current medication and dosage [ Time Frame: 12 MONTHS ]
  2. Vision complications [ Time Frame: 12 MONTHS ]
    Recorded as adverse events such as blurred vision, double vision, or water eyes

  3. Motor impairment [ Time Frame: 12 MONTHS ]
    Assessed through a battery of test with a performance score (range: 1-100)

  4. Cognitive impairment [ Time Frame: 12 MONTHS ]
    Assessed through a battery of test with a performance score (range: 1-100)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04117035

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Contact: Jianhua Wu, PhD 0113 343 3431
Contact: Sakina Edwebi, PhD 07825814912

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United Kingdom
Sheffield royal hallamshire hospital Recruiting
Sheffield, United Kingdom
Contact: Alison Loescher, PhD         
Sponsors and Collaborators
University of Leeds
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Principal Investigator: Jianhua Wu, PhD University of Leeds
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Responsible Party: Jianhua Wu, Associate professor in Medical Statistics/Biostatistics, University of Leeds Identifier: NCT04117035    
Other Study ID Numbers: 255351
115658 ( Other Identifier: University of Leeds )
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianhua Wu, University of Leeds:
multiple sclerosis
trigeminal neuralgia
Quality of life
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neurologic Manifestations
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases