Clinical trial NCT02791997: Audition After a Lesion and in Migraine. (AuditionPostLesion)
Official title: Consequences of a Brain Lesion or of Migraine on Auditory Processing: Attention, Memory and Emotion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders, Brain
Keywords: Audition
Stroke
Migraine
Attention
Short-term memory,
Emotions
EEG
MEG
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The project studies auditory processing after brain damage (in temporal and/or frontal areas) and in migraine. The auditory processes investigated are attention, short-term memory, sound-induced emotions. To characterize auditory deficits after brain damage or in migraine, neuropsychological assessments are combined with neurophysiological markers (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging: MRI).


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 80
* MEG/MRI compatibility
* Motivation to participate efficiently in the study
* No severe hearing loss
* Informed consent to participate in the study
* Affiliation to social security
* For brain-damaged patients : no need for medical assistance; focal temporal and/or frontal lesion; no major cognitive impairment; ability to understand and apply the instructions for neuropsychological testing; testing at least one-month after the event resulting in brain damage; absence of neurological and psychiatric disorders besides the lesion
* For migraine patients: no need for medical assistance; migraine diagnosis; no major cognitive impairment; ability to understand and apply the instructions for neuropsychological testing; absence of neurological and psychiatric disorders besides the migraine
* Healthy participants: absence of neurological and psychiatric disorders

Exclusion Criteria:

* Age below 18 or above 80
* MRI scanning not possible: artificial cardiac pacemaker, insulin pump, metallic prosthesis, intra-cerebral clip, claustrophobia
* MEG acquisition not possible: large heads, neurostimulator, metal in the head or the body.
* Pregnant or breast-feeding women

Primary outcomes:
measure: Percentages of correct responses in Neuropsychological tests
timeFrame: up to 2 months
measure: reaction times in Neuropsychological tests
timeFrame: up to 2 months
Secondary outcomes:
measure: Event-Related Potentials (EEG) in Neurophysiological tests
timeFrame: up to 2 months
measure: Event-Related Fields (MEG) in Neurophysiological tests
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Unité 201, Hôpital Neurologique
city: Lyon
country: France
facility: Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse
Study officials:
affiliation: Unité 201, Hôpital Neurologique, Hospices Civils de Lyon
name: Norbert NIGHOGHOSSIAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Masson R, Demarquay G, Meunier D, Leveque Y, Hannoun S, Bidet-Caulet A, Caclin A. Is Migraine Associated to Brain Anatomical Alterations? New Data and Coordinate-Based Meta-analysis. Brain Topogr. 2021 May;34(3):384-401. doi: 10.1007/s10548-021-00824-6. Epub 2021 Feb 19.