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

August 8, 2017 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Franche-Comte
      • Besancon, Franche-Comte, France, 25000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1 for familiar and unfamiliar songs and day 14 for newly learned songs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1 for familiar and unfamiliar songs and day 14 for newly learned songs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Pierre Vandel, MD, PhD, Service de psychiatrie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2015

Primary Completion (Anticipated)

August 20, 2018

Study Completion (Anticipated)

August 20, 2018

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2014/51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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