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Audition After a Lesion and in Migraine. (AuditionPostLesion)

Primary Purpose

Migraine Disorders, Brain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological tests
Neurophysiological tests
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Migraine Disorders, Brain focused on measuring Audition, Stroke, Migraine, Attention, Short-term memory,, Emotions, EEG, MEG

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Unité 201, Hôpital Neurologique
  • Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Brain-damaged patients

Control participants

Migraine patients

Arm Description

Outcomes

Primary Outcome Measures

Percentages of correct responses in Neuropsychological tests
reaction times in Neuropsychological tests

Secondary Outcome Measures

Event-Related Potentials (EEG) in Neurophysiological tests
Event-Related Fields (MEG) in Neurophysiological tests

Full Information

First Posted
May 27, 2016
Last Updated
August 30, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02791997
Brief Title
Audition After a Lesion and in Migraine. (AuditionPostLesion)
Official Title
Consequences of a Brain Lesion or of Migraine on Auditory Processing: Attention, Memory and Emotion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 6, 2015 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Brain
Keywords
Audition, Stroke, Migraine, Attention, Short-term memory,, Emotions, EEG, MEG

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain-damaged patients
Arm Type
Experimental
Arm Title
Control participants
Arm Type
Experimental
Arm Title
Migraine patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neuropsychological tests
Intervention Description
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
Intervention Type
Other
Intervention Name(s)
Neurophysiological tests
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentages of correct responses in Neuropsychological tests
Time Frame
up to 2 months
Title
reaction times in Neuropsychological tests
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Event-Related Potentials (EEG) in Neurophysiological tests
Time Frame
up to 2 months
Title
Event-Related Fields (MEG) in Neurophysiological tests
Time Frame
up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert NIGHOGHOSSIAN, MD
Organizational Affiliation
Unité 201, Hôpital Neurologique, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité 201, Hôpital Neurologique
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33606142
Citation
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.
Results Reference
derived

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Audition After a Lesion and in Migraine. (AuditionPostLesion)

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