Audition After a Lesion and in Migraine. (AuditionPostLesion)

Migraine Disorders, Brain Clinical Trial

Official title:

Consequences of a Brain Lesion or of Migraine on Auditory Processing: Attention, Memory and Emotion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791997
• Other study ID #: 69HCL14_0202
• Secondary ID: 2014-A01289-38
• Status: Completed
• Phase: N/A
• Start date: February 6, 2015
• Est. completion date: September 9, 2020

Study information

• Verified date: August 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine Disorders, Brain

Intervention

Other:
• Neuropsychological tests
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
• Neurophysiological tests
Neurophysiological tests consist in the recording of EEG and/or MEG signals while realizing the neuropsychological tests, as well as MRI scanning to characterize the patients' brain lesions and reconstruct the brain sources of surface EEG/MEG signals.

Locations

Country	Name	City	State
France	Unité 201, Hôpital Neurologique	Bron
France	Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of correct responses in Neuropsychological tests		up to 2 months
Primary	reaction times in Neuropsychological tests		up to 2 months
Secondary	Event-Related Potentials (EEG) in Neurophysiological tests		up to 2 months
Secondary	Event-Related Fields (MEG) in Neurophysiological tests		up to 2 months