A Personalised Radiosurgery Procedure for People With Trigeminal Neuralgia to Improve Pain, Quality of Life and Reduce Complications
Sponsored by University of Leeds
About this trial
Last updated 2 years ago
Study ID
255351
Status
Recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18 to 100 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended a year ago
What is this trial about?
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.
What are the participation requirements?
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
1. Have no capacity to complete written informed consent
2. Do not understand English
3. Repeat GKRS treatment