RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02708810
• Other study ID #: IRB-150608005
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: October 2025

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Device:
• Unframed Virtual Cone
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.

Radiation:
• 80 Gy Radiation

Locations

Country	Name	City	State
United States	Hazelrig-Salter Radiation Oncology Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment		3 Month Follow-Up Visit
Primary	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	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
Secondary	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
Secondary	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