NCT02708810

RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2016-03-15
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States