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Audition After a Lesion and in Migraine. (AuditionPostLesion)

This study is currently recruiting participants.
Verified January 2017 by Hospices Civils de Lyon
Sponsor:
ClinicalTrials.gov Identifier:
NCT02791997
First Posted: June 7, 2016
Last Update Posted: January 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
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).

Condition Intervention
Migraine Disorders, Brain Other: Neuropsychological tests Other: Neurophysiological tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Consequences of a Brain Lesion or of Migraine on Auditory Processing: Attention, Memory and Emotion

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Percentages of correct responses in Neuropsychological tests [ Time Frame: up to 2 months ]
  • reaction times in Neuropsychological tests [ Time Frame: up to 2 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 335
Study Start Date: February 2015
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brain-damaged patients Other: Neuropsychological tests
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
Other: 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.
Experimental: Control participants Other: Neuropsychological tests
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
Other: 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.
Experimental: Migraine patients Other: Neuropsychological tests
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
Other: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791997


Contacts
Contact: Norbert NIGHOGHOSSIAN, MD 4 72 68 13 22 ext +33 norbert.nighoghossian@chu-lyon.fr
Contact: Anne CACLIN 472138904 ext +33 anne.caclin@inserm.fr

Locations
France
Unité 201, Hôpital Neurologique Recruiting
Bron, France, 69500
Contact: Norbert NIGHOGHOSSIAN, MD    04 72 68 13 22 ext +33    norbert.nighoghossian@chu-lyon.fr   
Contact: Anne CACLIN, MD    472138904 ext +33    anne.caclin@inserm.fr   
Principal Investigator: Norbert NIGHOGHOSSIAN, MD         
Sub-Investigator: Yves Berthezène, MD         
Sub-Investigator: Julien Jung, MD         
Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse Recruiting
Lyon, France, 69004
Contact: Geneviève Demarquay, MD    4 72 07 24 48 ext +33    genevieve.demarquay@chu-lyon.fr   
Contact: Anne CACLIN    472138904 ext +33    anne.caclin@inserm.fr   
Principal Investigator: Geneviève Demarquay, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Norbert NIGHOGHOSSIAN, MD Unité 201, Hôpital Neurologique, Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02791997     History of Changes
Other Study ID Numbers: 69HCL14_0202
First Submitted: May 27, 2016
First Posted: June 7, 2016
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
Audition
Stroke
Migraine
Attention
Short-term memory,
Emotions
EEG
MEG

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases