A Personalised Radiosurgery Procedure for People With Trigeminal Neura
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)
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Gamma Knife Radiosurgery (GKRS) personalised procedure
Placebo
- GKRS standard care
What it measured
Main measures
Barrow Neurological Institute (BNI) pain measure
6 MONTHS
PainBarrow Neurological Institute (BNI) numbness measure
6 MONTHS
Other measures (4)
Current medication and dosage
12 MONTHS
Vision complications
12 MONTHS
VisionSafetyMotor impairment
12 MONTHS
Cognitive impairment
12 MONTHS
Thinking and memory
Who could take part
MS (type not specified) · 18 to 100
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Nov 2019
Main results due
Dec 2022
Finished
Dec 2023