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NCT Number: NCT02708810

RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35233, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Face Mask

80 Gy Radiation

Radiation

Other names: Radiosurgery

Primary outcomes

  1. Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment

    Time frame: 3 Month Follow-Up Visit

  2. The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms.

    Time frame: 1 Year

    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".

Secondary outcomes

  1. Number of Participants with treatment-related adverse events

    Time frame: 1 Year

    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.

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

    Time frame: 1 Year

    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.

  3. Patient Satisfaction Scores

    Time frame: 3 Month Follow-Up Visit

    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?

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Mar 15, 2016
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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