Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus

Last updated: December 11, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Seizure Disorders

Tinnitus

Treatment

acoustics tests, Questionaries,

MRI

Clinical Study ID

NCT04717388
APHP200761
  • Ages > 18
  • All Genders

Study Summary

the investigators have recently shown that patients with drug-resistant temporal lobe epilepsy who have undergone brain surgery targeting the medial temporal lobe structures were more likely to develop tinnitus postoperatively. This discovery of a vulnerability to tinnitus associated with medial temporal lobe surgery to eliminate drug-refractory epileptic seizures provides a new clinical model of tinnitus, targeting temporal lobe regions as generators or mediators of this hearing disorder. The objective of this project is to study the impact of tinnitus on the cognitive, emotional, psychoacoustic and cerebral functioning associated with this hearing disorder, and to clarify the pathophysiology of tinnitus by comparing different groups of individuals with tinnitus (surgical epileptic patients or non-surgical ORL patients) to matched tinnitus-free groups (surgical tinnitus-free cases and healthy controls volunteer).

Eligibility Criteria

Inclusion

Common Criteria for Inclusion :

  • Age ≥ 18 years old

  • Good written and oral comprehension of the French language

  • Person affiliated to a Social Security scheme

  • Informed consent signed by the participant

  • Normal or corrected vision

  • Absence of known pre-existing neurological and/or degenerative disorders

Group Specific Inclusion Criteria :

Tinnitus+ Group - Suffering from subjective uni- or bilateral tinnitus, chronic (>3 months) and stable (no period of remission).

Chir+ Group

  • Surgically treated for drug-resistant epilepsy of the temporal lobe (including theamygdala).

Group Tinnitus-

  • Not suffering from tinnitus Group Chir-

  • Non epileptic

  • Not having undergone surgical treatment of the temporal lobe (including the tonsil)

Exclusion

Exclusion criteria:

  • Presence of severe or profound deafness, uni or bilateral.

  • Under legal protection (guardianship, curators, etc.)

Additional criteria for patients completing visit V2 :

  • MRI contraindicated or claustrophobic

  • Pregnant or breastfeeding woman.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: acoustics tests, Questionaries,
Phase:
Study Start date:
June 15, 2021
Estimated Completion Date:
April 15, 2029

Study Description

Tinnitus (known as "ringing in the ears") is a disabling medical condition. Its psychosocial impact is substantial, including anxiety, depression, stress, irritability, concentration and sleep disorder leading to detrimental effects on communication, education, professional fulfillment, mental health and quality of life. The cerebral bases of tinnitus and its consequence on human hearing health have received a lot of attention in the scientific literature. Yet, the relationship between the neurobiological dysfunction, psychological processes and clinical semiology of tinnitus remains poorly understood. Considering the current gaps in knowledge, there is a real need for clinical investigations into tinnitus-related brain changes and rigorous hearing, psycho-emotional, and cognitive assessments. the investigators recent discovery of a vulnerability to tinnitus associated with medial temporal lobe surgery (to treat refractory epilepsy) provides a new clinical model, which targets the temporal lobe regions as a tinnitus generator or mediator of its severity. The goal of this collaborative interdisciplinary study is to advance knowledge about the pathophysiology of tinnitus, as well as the socio-emotional, cognitive and psychoacoustic aspects associated to this hearing disorder. the investigators will first, characterize the subjective and self-reported hearing disorders with objective psychoacoustic, cognitive and affective measures in tinnitus sufferers and second, clarify the cerebral network underlying tinnitus and elucidate the role temporal lobe regions in the brain networks at play in surgical and non-surgical tinnitus. To this end, individuals with and without tinnitus, who had undergone or not a surgery will be compared in a 2 by 2 design. Investigating different patient cohorts with tinnitus who are well matched to both, healthy control populations and vulnerable clinical populations, without tinnitus is a valuable contribution of our proposal. Moreover, the psychological and hearing profiles of people with tinnitus will be examined in relation with their brain morphology and connectivity profiles.The project builds upon the internationally recognized leadership of the PI and her collaborators in the fields of auditory cognition and its neurobiological bases using neuropsychological, psychoacoustic, and neuroimaging methods in clinical populations. The members of the investigators consortium have all the necessary and unique expertise to carry out this innovative and interdisciplinary project.

Connect with a study center

  • Hôpital Européen Georges Pompidou

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Pitié-Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences

    Paris, 75013
    France

    Active - Recruiting

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