RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
Time Frame: 3 Month Follow-Up Visit
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
- Mean of Quality of Life Scores as measured by SF-36 Questionnaire(1 Year)
- Patient Satisfaction Scores(3 Month Follow-Up Visit)
- Number of Participants with treatment-related adverse events(1 Year)
Investigators
John Fiveash, MD
Principal Investigator
University of Alabama at Birmingham