NCT02122042Unknown1 期
Hyperbaric Oxygen Therapy Can Improve Cognitive Deficits Post Low Grade Glioma Removal Surgery - Randomized Prospective Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 62
- 试验地点
- 1
- 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 impairment after low grade glioma tumor removal surgery
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 low grade glioma (WHO I-II) removal surgery 3-12 months prior to the inclusion in the study.
- •All patients have to have persistent cognitive impairment (Mindstream score should be at least one SD lower than average) 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; Previous brain radiotherapy and/or radiosurgery. Steroids dependence Chemotherapy in the past month or scheduled in the next 3 months 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.
研究组 & 干预措施
HBOT
Experimental
Group will be treated with HBOT for 60 treatments in 3 months.
干预措施: HBOT (Biological)
Control/Crossover
Other
Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.
干预措施: HBOT (Biological)
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 (1)
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