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

Primary Purpose

Cushing's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual radial task in 3D
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cushing's Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital du Haut-Lévêque

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients

Controls

Arm Description

Virtual radial task in 3D

Virtual radial task in 3D

Outcomes

Primary Outcome Measures

Percentage of right answers at virtual radial task in 3D
Comparison of right answers in patients cured of Cushing's disease and in controls.

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2015
Last Updated
November 10, 2015
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02603653
Brief Title
Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease
Acronym
MEMOCUSH
Official Title
Cognitive Sequels of Cushing Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Virtual radial task in 3D
Arm Title
Controls
Arm Type
Experimental
Arm Description
Virtual radial task in 3D
Intervention Type
Device
Intervention Name(s)
Virtual radial task in 3D
Intervention Description
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 Outcome Measure Information:
Title
Percentage of right answers at virtual radial task in 3D
Description
Comparison of right answers in patients cured of Cushing's disease and in controls.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
General Quality of life
Description
Comparison of quality of life of patients and controls with validated general questionnaire : SF-36 (SF for Short Form health survey)
Time Frame
baseline
Title
Specific Quality of life for Cushing's Disease
Description
Comparison of quality of life of patients and controls with validated specific questionnaire for Cushing's Disease : Cushing-QoL
Time Frame
baseline
Title
Number of participants with anxiety
Description
Evaluation of anxiety in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)
Time Frame
baseline
Title
Number of participants with depression with MADRS
Description
Evaluation of depression in the two groups with Montgomery and Asberg Depression Rating Scale (MADRS) (questionnaire)
Time Frame
baseline
Title
Number of participants with depression with HADS
Description
Evaluation of depression in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)
Time Frame
baseline
Title
Intensity of Cushing's syndrome
Description
Intensity of Cushing's disease will be evaluated with mean of free urinary cortisol. Hypothesis : intensity of hypercortisolism is correlated with sequels after cure.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine Tabarin, Pr
Email
antoine.tabarin@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Tabarin, Pr
Organizational Affiliation
Hôpital Haut Lévêque - Pessac (France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital du Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Tabarin, Pr

12. IPD Sharing Statement

Citations:
PubMed Identifier
36004342
Citation
Pupier E, Santos A, Etchamendy N, Lavielle A, Ferriere A, Marighetto A, Resmini E, Cota D, Webb SM, Tabarin A. Impaired quality of life, but not cognition, is linked to a history of chronic hypercortisolism in patients with Cushing's disease in remission. Front Endocrinol (Lausanne). 2022 Aug 8;13:934347. doi: 10.3389/fendo.2022.934347. eCollection 2022.
Results Reference
derived

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

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