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Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients (RIHANNA)

Primary Purpose

Alzheimer Disease, Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high-density electroencephalography
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring electroencephalography (EEG)

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being right-handed
  • recorded consent
  • For Alzheimer patients: Mini Mental Status Examination (MMSE) score >= 18
  • For patients with a depressive disorder : Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) and Montgomery-Asberg depression rating scale (MADRS) score >= 25
  • For healthy controls : no cognitive deficit, MADRS score < 25, no depressive disorder according to DSM IV

Exclusion Criteria:

  • Auditory deficit
  • contraindication to a high-density electroencephalography exam
  • refusal to participate in the study

Sites / Locations

  • CHRU BesançonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Alzheimer patients

patients with a depressive disorder

Healthy controls

Arm Description

Cerebral measurements from high-density electroencephalography are recorded in Alzheimer patients. The same protocol is applied in the 3 arms

Cerebral measurements from high-density electroencephalography are recorded in patients with a depressive disorder. The same protocol is applied in the 3 arms

Cerebral measurements from high-density electroencephalography are recorded in healthy controls

Outcomes

Primary Outcome Measures

Amplitude of event-related potentials
Measurements of the amplitude of event-related potentials with electroencephalography at day one for familiar and unfamiliar songs and after 2 weeks for newly learned songs

Secondary Outcome Measures

Spectral power
Measurements of the spectral power with electroencephalography at day one for familiar and unfamiliar songs and after 2 weeks for newly learned songs

Full Information

First Posted
July 12, 2016
Last Updated
August 8, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02840045
Brief Title
Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients
Acronym
RIHANNA
Official Title
Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2015 (Actual)
Primary Completion Date
August 20, 2018 (Anticipated)
Study Completion Date
August 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to use a new method to differentiate mnesic abilities of early alzheimer patients and patients with a depressive disorder. This method is based on the recording of cerebral activity while patients listen to familiar, unfamiliar and newly-learned music.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Depression
Keywords
electroencephalography (EEG)

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
Alzheimer patients
Arm Type
Experimental
Arm Description
Cerebral measurements from high-density electroencephalography are recorded in Alzheimer patients. The same protocol is applied in the 3 arms
Arm Title
patients with a depressive disorder
Arm Type
Experimental
Arm Description
Cerebral measurements from high-density electroencephalography are recorded in patients with a depressive disorder. The same protocol is applied in the 3 arms
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
Cerebral measurements from high-density electroencephalography are recorded in healthy controls
Intervention Type
Device
Intervention Name(s)
high-density electroencephalography
Intervention Description
Musical stimulation during electroencephalography recording
Primary Outcome Measure Information:
Title
Amplitude of event-related potentials
Description
Measurements of the amplitude of event-related potentials with electroencephalography at day one for familiar and unfamiliar songs and after 2 weeks for newly learned songs
Time Frame
day 1 for familiar and unfamiliar songs and day 14 for newly learned songs
Secondary Outcome Measure Information:
Title
Spectral power
Description
Measurements of the spectral power with electroencephalography at day one for familiar and unfamiliar songs and after 2 weeks for newly learned songs
Time Frame
day 1 for familiar and unfamiliar songs and day 14 for newly learned songs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being right-handed recorded consent For Alzheimer patients: Mini Mental Status Examination (MMSE) score >= 18 For patients with a depressive disorder : Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) and Montgomery-Asberg depression rating scale (MADRS) score >= 25 For healthy controls : no cognitive deficit, MADRS score < 25, no depressive disorder according to DSM IV Exclusion Criteria: Auditory deficit contraindication to a high-density electroencephalography exam refusal to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien Gabriel, PhD
Phone
0033381219148
Email
dgabriel@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Magali Nicolier, PhD
Phone
0033381219007
Email
mnicolier@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Vandel, MD, PhD
Organizational Affiliation
Service de psychiatrie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Besançon
City
Besancon
State/Province
Franche-Comte
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien Gabriel, PhD
Phone
0033381219148
Email
dgabriel@chu-besancon.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
27131744
Citation
Gabriel D, Wong TC, Nicolier M, Giustiniani J, Mignot C, Noiret N, Monnin J, Magnin E, Pazart L, Moulin T, Haffen E, Vandel P. Don't forget the lyrics! Spatiotemporal dynamics of neural mechanisms spontaneously evoked by gaps of silence in familiar and newly learned songs. Neurobiol Learn Mem. 2016 Jul;132:18-28. doi: 10.1016/j.nlm.2016.04.011. Epub 2016 Apr 27.
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Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients

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