- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791997
Audition After a Lesion and in Migraine. (AuditionPostLesion)
August 27, 2025 updated by: Hospices Civils de Lyon
Consequences of a Brain Lesion or of Migraine on Auditory Processing: Attention, Memory and Emotion
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
262
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 Locations
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-
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Bron, France, 69500
- Unité 201, Hôpital Neurologique
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Lyon, France, 69004
- Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse
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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
14 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brain-damaged patients
|
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
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.
|
|
Experimental: Control participants
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Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
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.
|
|
Experimental: Migraine patients
|
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentages of correct responses in Neuropsychological tests
Time Frame: up to 2 months
|
up to 2 months
|
|
reaction times in Neuropsychological tests
Time Frame: up to 2 months
|
up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Event-Related Potentials (EEG) in Neurophysiological tests
Time Frame: up to 2 months
|
up to 2 months
|
|
Event-Related Fields (MEG) in Neurophysiological tests
Time Frame: up to 2 months
|
up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Norbert NIGHOGHOSSIAN, MD, Unité 201, Hôpital Neurologique, Hospices Civils de Lyon
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.
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 6, 2015
Primary Completion (Actual)
September 9, 2020
Study Completion (Actual)
September 9, 2020
Study Registration Dates
First Submitted
May 27, 2016
First Submitted That Met QC Criteria
June 6, 2016
First Posted (Estimated)
June 7, 2016
Study Record Updates
Last Update Posted (Estimated)
September 4, 2025
Last Update Submitted That Met QC Criteria
August 27, 2025
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL14_0202
- 2014-A01289-38 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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