Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: acoustics tests, Questionaries,, MRI.
- Who it may be relevant to
- Registry conditions: Tinnitus, Epilepsy, Temporal Lobe. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus
Overview
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).
Detailed 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.
Interventions
- Other acoustics tests, Questionaries,
acoustics tests at V1 Questionaries at V1 * cognitive * emotional * auditory - Radiation MRI
Anatomical and functional MRI at V2
Primary outcome measures
- Evaluation of the impact of tinnitus on executive cognitive functioning [Time frame: at the second visit, maximum 6 month after first visit.]
Secondary outcome measures (12)
- Emotional functioning (anxiety and depression) [Time frame: at the second visit, maximum 6 month after first visit.]
- psycho-acoustic functioning [Time frame: at the second visit, maximum 6 month after first visit.]
- psycho-acoustic functioning [Time frame: at the second visit, maximum 6 month after first visit.]
- psycho-acoustic functioning [Time frame: at the second visit, maximum 6 month after first visit.]
- psycho-acoustic functioning [Time frame: at the second visit, maximum 6 month after first visit.]
- psycho-acoustic functioning [Time frame: at the second visit, maximum 6 month after first visit.]
- psycho-acoustic functioning [Time frame: at the second visit, maximum 6 month after first visit.]
- cognitive functioning, other than executive functioning (attention, memory) [Time frame: at the second visit, maximum 6 month after first visit.]
- cognitive functioning, other than executive functioning (attention, memory) [Time frame: at the second visit, maximum 6 month after first visit.]
- cognitive functioning, other than executive functioning (attention, memory) [Time frame: at the second visit, maximum 6 month after first visit.]
- cognitive functioning, other than executive functioning (attention, memory) [Time frame: at the second visit, maximum 6 month after first visit.]
- cognitive functioning, other than executive functioning (attention, memory) [Time frame: at the second visit, maximum 6 month after first visit.]
Eligibility criteria
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 the amygdala).
Group Tinnitus-
- Not suffering from tinnitus Group Chir-
- Non epileptic
- Not having undergone surgical treatment of the temporal lobe (including the tonsil)
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences — Paris
- Hôpital Européen Georges Pompidou — Paris
Identifiers
NCT: NCT04717388 · APHP200761