Migraine Disorders, BrainNCT02791997
Audition After a Lesion and in Migraine. (AuditionPostLesion)
A study testing Neuropsychological tests and Neurophysiological tests in people with Migraine Disorders, Brain, run by Hospices Civils de Lyon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Brain
- What is being tested?
- Neuropsychological tests and Neurophysiological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Feb 2015to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Unité 201, Hôpital Neurologique
Bron, 69500
Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse
Lyon, 69004
About this study
Official title: 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).
- Conditions
- Migraine Disorders, Brain
- Being tested
- Neuropsychological tests, Neurophysiological tests
- Keywords
- Audition, Stroke, Migraine, Attention, Short-term memory,, Emotions, EEG, MEG
- Medical subject headings
- Migraine Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsOther
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
Neurophysiological testsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Brain-damaged patients | Experimental | Not described Receives: Other: Neuropsychological tests; Other: Neurophysiological tests |
| Control participants | Experimental | Not described Receives: Other: Neuropsychological tests; Other: Neurophysiological tests |
| Migraine patients | Experimental | Not described Receives: Other: Neuropsychological tests; Other: Neurophysiological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of correct responses in Neuropsychological tests
Measured: up to 2 months
reaction times in Neuropsychological tests
Measured: up to 2 months
Secondary outcomes (2)
Event-Related Potentials (EEG) in Neurophysiological tests
Measured: up to 2 months
Event-Related Fields (MEG) in Neurophysiological tests
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start6 Feb 2015
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine Disorders, BrainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert NIGHOGHOSSIAN, MD, Principal investigator, Unité 201, Hôpital Neurologique, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791997
- Sponsor's protocol ID
- 69HCL14_0202
- Other IDs
- 2014-A01289-38
- Status last verified
- Aug 2022
- First submitted
- 27 May 2016
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33606142Masson R, ElShafei A, Demarquay G, Fornoni L, Leveque Y, Caclin A, Bidet-Caulet A. Deficient inhibition of irrelevant visual information in migraine: A magnetoencephalography study of alpha-band activity. Headache. 2026 Jul-Aug;66(7):1459-1473. doi: 10.1111/head.70108. Epub 2026 Jun 15.
PubMed 42290392
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of a Brain Lesion or of Migraine on Auditory Processing: Attention, Memory and Emotion
- ClinicalTrials.gov ID
- NCT02791997
- Acronym / sponsor ID
- 69HCL14_0202
- Conditions
- Migraine Disorders, Brain
- Keywords
- Audition, Stroke, Migraine, Attention, Short-term memory,, Emotions, EEG, MEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain-damaged patients | Experimental | Other: Neuropsychological tests, Other: Neurophysiological tests |
| Control participants | Experimental | Other: Neuropsychological tests, Other: Neurophysiological tests |
| Migraine patients | Experimental | Other: Neuropsychological tests, Other: Neurophysiological tests |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testsNeuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons. | Other | Brain-damaged patients, Control participants, Migraine patients |
| Neurophysiological testsNeurophysiological 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. | Other | Brain-damaged patients, Control participants, Migraine patients |
Primary outcome
Percentages of correct responses in Neuropsychological tests
Time frame: up to 2 months
reaction times in Neuropsychological tests
Time frame: up to 2 months
2 secondary outcomes
Event-Related Potentials (EEG) in Neurophysiological tests
Time frame: up to 2 months
Event-Related Fields (MEG) in Neurophysiological tests
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 33606142Masson 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.
- Derived from this study: PubMed 42290392Masson R, ElShafei A, Demarquay G, Fornoni L, Leveque Y, Caclin A, Bidet-Caulet A. Deficient inhibition of irrelevant visual information in migraine: A magnetoencephalography study of alpha-band activity. Headache. 2026 Jul-Aug;66(7):1459-1473. doi: 10.1111/head.70108. Epub 2026 Jun 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert NIGHOGHOSSIAN, MD principal investigator
Unité 201, Hôpital Neurologique, Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological tests and Neurophysiological tests in people with Migraine Disorders, Brain, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of correct responses in Neuropsychological tests (time frame: up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791997, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.