RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
- Conditions
- Trigeminal Neuralgia
- Interventions
- Device: Unframed Virtual ConeRadiation: 80 Gy Radiation
- Registration Number
- NCT02708810
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.
- Detailed Description
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. To measure pain relief after Virtual Cone radiosurgery utilizing the Barrow Neurologic Institute Pain Intensity Score (BNI).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
- Patients must have an ECOG status of 0, 1, or 2
- Patients must be at least 18 years of age
- Life expectancy must be greater than 12 months
- MRI of brain within prior 12 months to confirm lack of other causes of facial pain
- All patients must be given written informed consent
- Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
- Patients with atypical trigeminal neuralgia or headache pain syndromes
- Patients with pain associated with multiple sclerosis or base of skull tumor
- Patients with medical contra-indications to MR imaging (e.g. pacemaker)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 80 Gy Radiation & Unframed Virtual Cone 80 Gy Radiation 80 Gy Virtual Cone Radiosurgery unframed (face mask) 80 Gy Radiation & Unframed Virtual Cone Unframed Virtual Cone 80 Gy Virtual Cone Radiosurgery unframed (face mask)
- Primary Outcome Measures
Name Time Method Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment 3 Month Follow-Up Visit The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms. 1 Year Pain Relief Score designed to assess trigeminal neuralgia associated pain. It ranges from "I" being "no trigeminal pain, no medication" to "V" being "severe pain/no pain relief".
- Secondary Outcome Measures
Name Time Method Mean of Quality of Life Scores as measured by SF-36 Questionnaire 1 Year Quality of Life (QOL) will be measured by SF-36. This questionnaire consists of 36 questions (items) measuring physical and mental health in relation to 8 health concepts: physical functioning, bodily pain, role of limitations due to physical health problems, role of limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perception. All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively.
Number of Participants with treatment-related adverse events 1 Year Based on the assessments of the patient and the responses provided by the patient in questionnaires, we will assess acute and late neurologic toxicities. All adverse events/toxicities will be assessed with the utilization of CTCAE v.4.0.
Patient Satisfaction Scores 3 Month Follow-Up Visit 3 months following the completion of radiosurgery, the patient will be asked the following two questions: 1) Would you have the radiosurgery procedure again? 2) Would you recommend it to friends and family?
Trial Locations
- Locations (1)
Hazelrig-Salter Radiation Oncology Center
🇺🇸Birmingham, Alabama, United States