NCT02084927Unknown1 期
Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Neurocognitive functions
研究概览
简要总结
The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post intracranial meningioma removal surgery 3-12 months prior to the inclusion in the study.
- •All patients have to have persistent cognitive or neurological complaints regarding without noticeable improvement during the last month prior to their enrolment.
- •Age 18 years or older.
排除标准
- •Dynamic neurologic/cognitive improvement or worsening during the past month;
- •Evidence of dynamic cognitive/neurological improvement in the last month.
- •Previous brain radiotherapy and/or radiosurgery.
- •Steroids dependence
- •Seizures 1 month previous to inclusion
- •Had been treated with HBOT for any other reason 1 month prior to inclusion;
- •Have any other indication for HBOT;
- •Chest pathology incompatible with pressure changes;
- •Inner ear disease;
- •Patients suffering from claustrophobia;
- •Inability to sign written informed consent;
- •Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.
结局指标
主要结局
Neurocognitive functions
时间窗: 6 months
Cognitive function will be assessed using the one-hour Mindstreams Computerized Cognitive Test Battery at baseline, 3 months and 6 months to intervention.
次要结局
- Quality of Life(6 months)
研究者
Assaf Harofeh MC
Shai Efrati
Assaf-Harofeh Medical Center
研究点 (2)
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