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Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease (MEMOCUSH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02603653
First Posted: November 13, 2015
Last Update Posted: November 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
  Purpose
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.

Condition Intervention
Cushing's Disease Device: Virtual radial task in 3D

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cognitive Sequels of Cushing Syndrome

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: November 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
Virtual radial task in 3D
Device: Virtual radial task in 3D
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.
Experimental: Controls
Virtual radial task in 3D
Device: Virtual radial task in 3D
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603653


Contacts
Contact: Antoine Tabarin, Pr antoine.tabarin@chu-bordeaux.fr

Locations
France
Hôpital du Haut-Lévêque Not yet recruiting
Pessac, France, 33604
Contact: Antoine Tabarin, Pr         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Antoine Tabarin, Pr Hôpital Haut Lévêque - Pessac (France)
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02603653     History of Changes
Other Study ID Numbers: C15-02
IDRCB ( Registry Identifier: 2015-A00617-42 )
First Submitted: November 3, 2015
First Posted: November 13, 2015
Last Update Posted: November 13, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site