Clinical trial NCT04717388: Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
Official title: Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Epilepsy, Temporal Lobe
Keywords: Tinnitus
Epilepsy
Cognitive Functioning
Brain connectivity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

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.

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.

Primary outcomes:
measure: Evaluation of the impact of tinnitus on executive cognitive functioning
timeFrame: at the second visit, maximum 6 month after first visit.
Secondary outcomes:
measure: Emotional functioning (anxiety and depression)
timeFrame: at the second visit, maximum 6 month after first visit.
measure: psycho-acoustic functioning
timeFrame: at the second visit, maximum 6 month after first visit.
measure: psycho-acoustic functioning
timeFrame: at the second visit, maximum 6 month after first visit.
measure: psycho-acoustic functioning
timeFrame: at the second visit, maximum 6 month after first visit.
measure: psycho-acoustic functioning
timeFrame: at the second visit, maximum 6 month after first visit.
measure: psycho-acoustic functioning
timeFrame: at the second visit, maximum 6 month after first visit.
measure: psycho-acoustic functioning
timeFrame: at the second visit, maximum 6 month after first visit.
measure: cognitive functioning, other than executive functioning (attention, memory)
timeFrame: at the second visit, maximum 6 month after first visit.
measure: cognitive functioning, other than executive functioning (attention, memory)
timeFrame: at the second visit, maximum 6 month after first visit.
measure: cognitive functioning, other than executive functioning (attention, memory)
timeFrame: at the second visit, maximum 6 month after first visit.
measure: cognitive functioning, other than executive functioning (attention, memory)
timeFrame: at the second visit, maximum 6 month after first visit.
measure: cognitive functioning, other than executive functioning (attention, memory)
timeFrame: at the second visit, maximum 6 month after first visit.
measure: the reorganization of functional and structural brain connectivity maps
timeFrame: at the third visit, maximum 18 month after the first visit
measure: the reorganization of functional and structural brain connectivity maps
timeFrame: at the third visit, maximum 18 month after the first visit
measure: the reorganization of functional and structural brain connectivity maps
timeFrame: at the third visit, maximum 18 month after the first visit
measure: the reorganization of functional and structural brain connectivity maps
timeFrame: at the third visit, maximum 18 month after the first visit
measure: Emotional functioning (stress)
timeFrame: at the second visit, maximum 6 month after first visit.
measure: Emotional functioning (Auditory recognition of emotions)
timeFrame: at the second visit, maximum 6 month after first visit.
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: AP-HP Hopital Pitié-Salpêtrière
name: Sophie Dupont, MD, Ph.D
role: STUDY_DIRECTOR
References: