RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

NCT02708810 | Active Not Recruiting

• 1 other identifier: IRB-150608005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trigeminal Neuralgia

Keywords

radiosurgery (RS); trigeminal neuralgia (TGN)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Participants with treatment-related adverse events

  1 Year

• Mean of Quality of Life Scores as measured by SF-36 Questionnaire

  1 Year

• Patient Satisfaction Scores

  3 Month Follow-Up Visit

Study Arms (1)

80 Gy Radiation & Unframed Virtual Cone

OTHER

80 Gy Virtual Cone Radiosurgery unframed (face mask)

Device: Unframed Virtual Cone; Radiation: 80 Gy Radiation

Interventions

Unframed Virtual Cone 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.

Also known as: Face Mask

80 Gy Radiation & Unframed Virtual Cone

80 Gy Radiation RADIATION

Also known as: Radiosurgery

80 Gy Radiation & Unframed Virtual Cone

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Masks; Radiosurgery

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John Fiveash, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: March 15, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)