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NCT Number: NCT02603653

Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease

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.

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Key information

Conditions

Cushing's Disease Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital du Haut-Lévêque

Pessac, 33604, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients :

  • 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)

Exclusion criteria

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

Treatment and study plan

Virtual radial task in 3D

Device

The virtual radial task is a labyrinth in 3D with twelve ways. The primary aim of our study is the evaluation of persistent cognitive impairments (hippocampal memory) according to the responses of participants after instructions to choose the right way in the labyrinth.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. Number of participants with anxiety

    Time frame: baseline

    Evaluation of anxiety in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)

  4. 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)

  5. 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)

  6. 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.

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Cognitive Sequels of Cushing Syndrome

Acronym: MEMOCUSH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2015
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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