Personalized gamma knife radiosurgery for trigeminal neuralgia
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)
This study tests a new personalized approach to gamma knife surgery for people with trigeminal neuralgia to see if it can reduce pain and side effects better than the standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Leeds Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sheffield) |
| Trial ID | NCT04117035 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and impact of a personalized gamma knife radiosurgery (GKRS) treatment protocol compared to the standard protocol for patients with idiopathic or multiple sclerosis-related trigeminal neuralgia. Patients referred to the National Centre for Stereotactic Radiosurgery in Sheffield will undergo GKRS if eligible. The personalized approach aims to target the trigeminal nerve further from the brainstem to potentially reduce complications and improve pain relief and quality of life. The study will assess the effectiveness of this tailored treatment in managing pain and minimizing morbidity.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with idiopathic or multiple sclerosis-related trigeminal neuralgia who are scheduled for gamma knife radiosurgery.
Not a fit: Patients who do not understand English or have previously undergone gamma knife radiosurgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients suffering from trigeminal neuralgia.
How similar studies have performed: While gamma knife radiosurgery has been established as a safe treatment for trigeminal neuralgia, this personalized approach is novel and aims to improve upon existing protocols.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sheffield
- Sheffield royal hallamshire hospital — Sheffield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Jianhua Wu, PhD — University of Leeds
- Study coordinator: Jianhua Wu, PhD
- Email: j.h.wu@leeds.ac.uk
- Phone: 0113 343 3431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.