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Clinical Trials/NCT04717388
NCT04717388
Recruiting
Not Applicable

Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus

Assistance Publique - Hôpitaux de Paris2 sites in 1 country300 target enrollmentJune 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tinnitus
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
300
Locations
2
Primary Endpoint
Evaluation of the impact of tinnitus on executive cognitive functioning
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
April 15, 2029
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Evaluation of the impact of tinnitus on executive cognitive functioning

Time Frame: at the second visit, maximum 6 month after first visit.

Measurement of executive control using a stroop test in people with and without chronic tinnitus.

Secondary Outcomes

  • psycho-acoustic functioning(at the second visit, maximum 6 month after first visit.)
  • Emotional functioning (Auditory recognition of emotions)(at the second visit, maximum 6 month after first visit.)
  • Emotional functioning (anxiety and depression)(at the second visit, maximum 6 month after first visit.)
  • cognitive functioning, other than executive functioning (attention, memory)(at the second visit, maximum 6 month after first visit.)
  • the reorganization of functional and structural brain connectivity maps(at the third visit, maximum 18 month after the first visit)
  • Emotional functioning (stress)(at the second visit, maximum 6 month after first visit.)

Study Sites (2)

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