RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

Study Overview
=================
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).

Official Title
-----------------
RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

Conditions
-----------------
Trigeminal Neuralgia

Intervention / Treatment
-----------------
* Device: Unframed Virtual Cone
* Radiation: 80 Gy Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 80 Gy Radiation & Unframed Virtual Cone<br>80 Gy Virtual Cone Radiosurgery unframed (face mask) | Device: Unframed Virtual Cone<br>* A face mask (unframed) will be placed over the patient's face to keep their head from moving during the procedure. This will allow for very precise targeting. During the procedure, the study doctor will also confirm the exact location that needs to be treated using x-rays and optical imaging cameras. The face mask (unframed) will hold the patient's head to prevent it from moving and to focus the x-rays and aim them on the painful nerve in the patient's brain. For most patients, the actual time on the radiosurgery treatment machine is in the range of 30 to 60 minutes. The face mask (unframed) will be removed after the treatment.<br>* Other names: Face Mask;Radiation: 80 Gy Radiation<br> <br> * Other names: Radiosurgery;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with treatment-related adverse events | 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. | 1 Year | 
| Mean of Quality of Life Scores as measured by SF-36 Questionnaire | 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. | 1 Year | 
| Patient Satisfaction Scores | 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? | 3 Month Follow-Up Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiosurgery (RS), trigeminal neuralgia (TGN)