Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Autobiographical memory test (TEMPau) score
研究概览
简要总结
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes.
However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus.
The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.
Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for who radiotherapy is indicated will be recruited.
详细描述
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus, as specified in Nadel and Moscovitch model, the Multiple Trace Theory.
Autobiographical memory impairment issue is fundamental for identity construction. Prevent those impairments is important to quality of life improvement after such treatments.
The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.
A pilot study was conducted with 10 patients affected by left cavernous sinus meningioma divided in two groups: the first one with untreated patients and the second one with patients who received cavernous sinus irradiation between 2 and 5 years before pilot study. This study indicated autobiographical memory deterioration in two groups and a worsening in treated group. Study limits did not allow us to draw conclusions. That is why, sample size will be extended and patients with cavernous sinus meningioma or pituitary adenoma will be recruited because of proximity between cavernous sinus, pituitary gland and hippocampus. Investigators wish to recruit 30 patients with cavernous sinus and meningioma.
Investigators hope for confirm our results from pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35 and
- •Patient with:
- •meningioma of the cavernous sinus for which radiotherapy is planned
- •or a pituitary adenoma for which radiotherapy is planned
- •French Mother tongue
- •Person affiliated to national insurance
- •Person who give its verbal agreement to participate
排除标准
- •Presence of a serious psychiatric disorder (major depression, psychotic disorders, etc.) and central nervous system disease (epilepsy, multiple sclerosis, etc.).
- •Treatment with chemotherapy
- •General intellectual abilities deficient (IQ <80)
- •Extension front of their meningioma
- •Deficient Language Skills.
研究组 & 干预措施
Patients with brain tumors treated by radiotherapy
Patients with:
- meningioma of the cavernous sinus for which radiotherapy is planned
Or
- a pituitary adenoma for which radiotherapy is planned
干预措施: Evaluation of autobiographical memory (Other)
结局指标
主要结局
Autobiographical memory test (TEMPau) score
时间窗: Two years after irradiation treatment end
次要结局
- California Verbal Learning Test (CVLT) score(One and two years after irradiation treatment end)
- Revised Self Consciousness Scale (RSCS) score(One and two years after irradiation treatment end)
- Autobiographical memory test (TEMPau) score(One year after irradiation treatment end)
- Quality of life questionnaire (QLQC-30/BN20) score(One and two years after irradiation treatment end)