Clinical Trial: Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Cognitive Sequels of Cushing Syndrome

Brief Summary: 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.

Detailed Summary:
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Current Primary Outcome: Percentage of right answers at virtual radial task in 3D [ Time Frame: baseline ]

Comparison of right answers in patients cured of Cushing's disease and in controls.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • General Quality of life [ Time Frame: baseline ]
    Comparison of quality of life of patients and controls with validated general questionnaire : SF-36 (SF for Short Form health survey)
  • Specific Quality of life for Cushing's Disease [ Time Frame: baseline ]
    Comparison of quality of life of patients and controls with validated specific questionnaire for Cushing's Disease : Cushing-QoL
  • Number of participants with anxiety [ Time Frame: baseline ]
    Evaluation of anxiety in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)
  • Number of participants with depression with MADRS [ Time Frame: baseline ]
    Evaluation of depression in the two groups with Montgomery and Asberg Depression Rating Scale (MADRS) (questionnaire)
  • Number of participants with depression with HADS [ Time Frame: baseline ]
    Evaluation of depression in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)
  • Intensity of Cushing's syndrome [ Time Frame: baseline ]
    Intensity of Cushing's disease will be evaluated with mean of free urinary cortisol. Hypothesis : intensity of hypercortisolism is correlated with sequels after cure.


Original Secondary Outcome: Same as current

Information By: Institut National de la Santé Et de la Recherche Médicale, France

Dates:
Date Received: November 3, 2015
Date Started: November 2015
Date Completion: May 2017
Last Updated: November 10, 2015
Last Verified: November 2015