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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02840045
Other study ID # API/2014/51
Secondary ID
Status Recruiting
Phase N/A
First received July 12, 2016
Last updated August 8, 2017
Start date February 20, 2015
Est. completion date August 20, 2018

Study information

Verified date August 2017
Source Centre Hospitalier Universitaire de Besancon
Contact Damien Gabriel, PhD
Phone 0033381219148
Email dgabriel@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 20, 2018
Est. primary completion date August 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
high-density electroencephalography
Musical stimulation during electroencephalography recording

Locations

Country Name City State
France CHRU Besançon Besancon Franche-Comte

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 day 1 for familiar and unfamiliar songs and day 14 for newly learned songs
Secondary 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 day 1 for familiar and unfamiliar songs and day 14 for newly learned songs
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