Treatment of Adverse Radiation Effects After Gamma Knife Radiosurgery (GKS) by Hyperbaric Oxygen Therapy (HBO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Evaluation of clinical improvement
研究概览
简要总结
Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery (GKS) by treatment with hyperbaric oxygen therapy (HBO)
详细描述
Patients will be recruited on the basis of the presence of cerebral radionecrosis post gamma knife surgery, documented by both clinical examination (Rankin Scale) and instrumental imaging (MRI). They will be subjected to hyperbaric oxygen therapy HBO, and during treatment the patient performs clinical examination (Rankin Scale) for 24 sessions of HBO. Then they will have a break of 10-15 days during which also performs the instrumental survey (Magnetic Resonance Imaging). If the radionecrosis has regressed they will suspend the treatment otherwise continue up to a maximum of 40 treatment sessions of HBO
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
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 10 and 75 years
- •understanding of the Italian language
- •ability to understand the procedures and carrying out of the study
- •signing informed consent for adults and minors in use
- •underwent radiosurgery with clinical and instrumental signs of radiation necrosis
排除标准
- •younger than 10yrs old and older than 75yrs old
- •not capable to understand Italian language or to understand the protocol procedures and visits' scheme
- •informed consent not given
- •enrolled in another clinical trial
- •concomitant pathologies contraindicate HBO as: emphysema, asthma, epilepsy, claustrophobia; Paul Bert Syndrome, Lorrain Smith Syndrome
- •under disulfiram, doxorubicine, cisplatinum, mafenide acetate, bleomycins treatment
- •life expectancy less than 6 months
- •Rankin Scale >5
结局指标
主要结局
Evaluation of clinical improvement
时间窗: day 2 through day 25
By neurological evaluation (Ranking Scale)
次要结局
- Evaluation of the reduction of the extent of edema lesion documented by MRI(1-3 months)
- Measurement of complications from hyperbaric oxygen therapy and their severity(through study completion, an average of 1 year)