RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

NCT ID: NCT02708810

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2026-10-31

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).

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

80 Gy Radiation & Unframed Virtual Cone

80 Gy Virtual Cone Radiosurgery unframed (face mask)

Group Type: OTHER

Unframed Virtual Cone

Intervention Type: DEVICE

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.

80 Gy Radiation

Intervention Type: RADIATION

Interventions

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.

Intervention Type: DEVICE

80 Gy Radiation

Intervention Type: RADIATION

Other Intervention Names

Face Mask; Radiosurgery

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

John Fiveash, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Fiveash, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-150608005

Identifier Type: -

Identifier Source: org_study_id