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

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.
 
ClinicalTrials.gov Identifier: NCT02840045
Recruitment Status : Unknown
Verified August 2017 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : July 21, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Depression Device: high-density electroencephalography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of a New Neuroimaging Method Aimed to Differentiate Mnesic Abilities of Alzheimer and Depressed Patients
Actual Study Start Date : February 20, 2015
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alzheimer patients
Cerebral measurements from high-density electroencephalography are recorded in Alzheimer patients. The same protocol is applied in the 3 arms
Device: high-density electroencephalography
Musical stimulation during electroencephalography recording

Experimental: patients with a depressive disorder
Cerebral measurements from high-density electroencephalography are recorded in patients with a depressive disorder. The same protocol is applied in the 3 arms
Device: high-density electroencephalography
Musical stimulation during electroencephalography recording

Active Comparator: Healthy controls
Cerebral measurements from high-density electroencephalography are recorded in healthy controls
Device: high-density electroencephalography
Musical stimulation during electroencephalography recording




Primary Outcome Measures :
  1. Amplitude of event-related potentials [ Time Frame: day 1 for familiar and unfamiliar songs and day 14 for newly learned songs ]
    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 :
  1. Spectral power [ Time Frame: day 1 for familiar and unfamiliar songs and day 14 for newly learned songs ]
    Measurements of the spectral power with electroencephalography at day one for familiar and unfamiliar songs and after 2 weeks for newly learned songs



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02840045


Contacts
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Contact: Damien Gabriel, PhD 0033381219148 dgabriel@chu-besancon.fr
Contact: Magali Nicolier, PhD 0033381219007 mnicolier@chu-besancon.fr

Locations
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France
CHRU Besançon Recruiting
Besancon, Franche-Comte, France, 25000
Contact: Damien Gabriel, PhD    0033381219148    dgabriel@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Pierre Vandel, MD, PhD Service de psychiatrie
Publications:
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02840045    
Other Study ID Numbers: API/2014/51
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Centre Hospitalier Universitaire de Besancon:
electroencephalography (EEG)
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders