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RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

July 24, 2019

Overview

 

The RAD 1501 study aims to measure pain relief after Virtual Cone radiosurgery. The study uses the Barrow Neurologic Institute Pain Intensity Score (BNI) to measure the effects of the two arms of the study. Following the procedure, the study will record and assess neurologic toxicities, quality of life (based on a questionnaire), and patient satisfaction.

 

Study Information

 

In the study, the patient will have a face mask placed over their face to restrict motion during the procedure for specific targeting. The doctor will use x-rays and optical imaging cameras to determine the exact location of the procedure and will focus on the painful nerve in the patient’s brain. Patients are likely to spend 30-60 minutes in the radiosurgery treatment machine. Estimated enrollment is 100 and the study is due to be completed by October 2020.

 

Inclusion Criteria

 

  • Trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
  • ECOG status of 0, 1, or 2
  • Ages 18+
  • Life expectancy greater than 12 months
  • MRI of brain in the past 12 months to confirm lack of other causes of facial pain
  • 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)

 

Location

 

Birmingham, Alabama

Hazelrig-Salter Radiation Oncology Center

 

Sponsors/Collaborators

 

University of Alabama at Birmingham

Principal Investigator: John Fiveash, MD

Contact: Kristin K. Webbkriwebb@uab.edu

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