NCT02791997

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2020

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2022

Enrollment Period

5.6 years

First QC Date

May 27, 2016

Last Update Submit

August 27, 2025

Conditions

Migraine Disorders, Brain

Keywords

AuditionStrokeMigraineAttentionShort-term memory,EmotionsEEGMEG

Outcome Measures

Primary Outcomes (2)

  • Percentages of correct responses in Neuropsychological tests

    up to 2 months

  • reaction times in Neuropsychological tests

    up to 2 months

Secondary Outcomes (2)

  • Event-Related Potentials (EEG) in Neurophysiological tests

    up to 2 months

  • Event-Related Fields (MEG) in Neurophysiological tests

    up to 2 months

Study Arms (3)

Brain-damaged patients

EXPERIMENTAL
Other: Neuropsychological testsOther: Neurophysiological tests

Control participants

EXPERIMENTAL
Other: Neuropsychological testsOther: Neurophysiological tests

Migraine patients

EXPERIMENTAL
Other: Neuropsychological testsOther: Neurophysiological tests

Interventions

Neuropsychological testsOTHER

Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.

Brain-damaged patientsControl participantsMigraine patients
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.

Brain-damaged patientsControl participantsMigraine patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unité 201, Hôpital Neurologique

Bron, 69500, France

Location

Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Related Publications (1)

  • 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.

    PMID: 33606142BACKGROUND

MeSH Terms

Conditions

Migraine DisordersStroke

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Norbert NIGHOGHOSSIAN, MD

    Unité 201, Hôpital Neurologique, Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 7, 2016

Study Start

February 6, 2015

Primary Completion

September 9, 2020

Study Completion

September 9, 2020

Last Updated

September 4, 2025

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)