RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Study Details
Study Description
Brief Summary
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: 80 Gy Radiation & Unframed Virtual Cone 80 Gy Virtual Cone Radiosurgery unframed (face mask) |
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.
Other Names:
Radiation: 80 Gy Radiation
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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. [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 Outcome Measures
- Number of Participants with treatment-related adverse events [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.
- Mean of Quality of Life Scores as measured by SF-36 Questionnaire [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.
- Patient Satisfaction Scores [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?
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
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Patients must have an ECOG status of 0, 1, or 2
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Patients must be at least 18 years of age
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Life expectancy must be greater than 12 months
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MRI of brain within prior 12 months to confirm lack of other causes of facial pain
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All patients must be given written informed consent
Exclusion Criteria:
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Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
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Patients with atypical trigeminal neuralgia or headache pain syndromes
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Patients with pain associated with multiple sclerosis or base of skull tumor
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Patients with medical contra-indications to MR imaging (e.g. pacemaker)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hazelrig-Salter Radiation Oncology Center | Birmingham | Alabama | United States | 35233 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: John Fiveash, MD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-150608005