RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
研究概览
简要总结
To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment
时间窗: 3 Month Follow-Up Visit
The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms.
时间窗: 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".
次要结局
- 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)
研究者
John Fiveash, MD
Principal Investigator
University of Alabama at Birmingham