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)
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sheffield royal hallamshire hospital | Sheffield |
Lead Sponsor | Collaborator |
---|---|
University of Leeds |
United Kingdom,
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 |
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