Audition After a Lesion and in Migraine. (AuditionPostLesion)

Not Applicable

Completed

• Conditions: Migraine Disorders, Brain

• Registration Number: NCT02791997
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-06
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-07
• Primary Completion: 2020-09-09
• Study Completion: 2020-09-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentages of correct responses in Neuropsychological tests	up to 2 months
reaction times in Neuropsychological tests	up to 2 months

Secondary Outcome Measures

Name	Time	Method
Event-Related Fields (MEG) in Neurophysiological tests	up to 2 months
Event-Related Potentials (EEG) in Neurophysiological tests	up to 2 months

Trial Locations

Locations (2)

Unité 201, Hôpital Neurologique; 🇫🇷 Bron, France

Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France