Cognitive Sequels of Cushing Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of right answers at virtual radial task in 3D
研究概览
简要总结
Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease is responsible for increased morbidity and mortality. Recent studies have pinpointed the frequency of somatic sequelas and persistent alteration in quality of life despite the cure of the disease. More specifically, a few studies have described persistent psychopathology, maladaptive personality and cognitive impairments in patients with a history of Cushing's disease. Among these, hippocampal memory deficits have been found in the majority of studies, a finding that is consistent with the alterations described in hippocampal neurons during chronic exposure to glucocorticoids. However, the tools currently available to assess hippocampal-dependent memory are multiple, sometimes difficult to perform by clinicians and to analyze or may lack of diagnostic sensitivity. The investigators have recently developed an original tool, the virtual radial task in 3D, which has shown to be reliable to detect subtle alterations in hippocampal-dependent memory in several human diseases. The primary aim of the study is the evaluation of persistent cognitive impairments (hippocampal memory) in patients cured of Cushing's disease for at least one year using the virtual radial task in 3D and to compare it with that obtained with classical cognitive tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •history of Cushing's Disease
- •aged : 18 - 60 years
- •Biological remission of Cushing's disease for at least one year
- •Affiliation to Social Security
- •Informed consent signed by patient and investigator (at the latest the inclusion's day, before study's exams)
- •For controls :
- •People aged 18 to 60 years matched to patients for age, sex and educational level
- •Affiliation to Social Security
- •Informed consent signed by patient and investigator (at the latest the inclusion's day, before study's exams)
排除标准
- •For patients :
- •Persistent hypercortisolism (even mild)
- •Current treatment of hypercortisolism with drugs
- •Obesity (BMI >30 kg/m²)
- •Alcohol or drug addiction present or past
- •Growth hormone deficit
- •Diabetes mellitus with hemoglobin A1c > 7.5% and/or fasting blood glucose > 1.4 g/L
- •History of pituitary radiotherapy
- •History of cerebrovascular or neuro-cerebral disease
- •untreated dysthyroidism
- •Current psychotropic drug treatment
- •Pregnancy
- •Use of glucocorticoids in the last 3 months before study (aside hydrocortisone replacement therapy)
- •Excessive hydrocortisone replacement therapy (unadjusted to weight and/or with evening administration)
- •For controls :
- •Obesity (BMI >30 kg/m²)
- •Alcohol or drug addiction present or past
- •Current psychotropic drug treatment
- •History of cerebrovascular or neuro-cerebral disease
- •Current pregnancy
- •Chronical use of corticoid (> 1 month), current or past
- •Use of glucocorticoids in the last 3 months before study (aside hydrocortisone replacement therapy)
- •Diabetes mellitus with hemoglobin A1c > 7.5% and/or fasting blood glucose > 1.4 g/L
- •Obesity (BMI >30 kg/m²)
- •untreated dysthyroidism
结局指标
主要结局
Percentage of right answers at virtual radial task in 3D
时间窗: baseline
Comparison of right answers in patients cured of Cushing's disease and in controls.
次要结局
- Specific Quality of life for Cushing's Disease(baseline)
- General Quality of life(baseline)
- Number of participants with anxiety(baseline)
- Number of participants with depression with MADRS(baseline)
- Number of participants with depression with HADS(baseline)
- Intensity of Cushing's syndrome(baseline)