Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
- Conditions
- Epilepsy, Temporal LobeTinnitus
- Interventions
- Other: acoustics tests, Questionaries,Radiation: MRI
- Registration Number
- NCT04717388
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description impact of tinnitus on executive cognitive functioning acoustics tests, Questionaries, - impact of tinnitus on reorganization of functional/ structural brain connectivity maps MRI - impact of tinnitus on reorganization of functional/ structural brain connectivity maps acoustics tests, Questionaries, -
- Primary Outcome Measures
Name Time Method Evaluation of the impact of tinnitus on executive cognitive functioning 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 Outcome Measures
Name Time Method psycho-acoustic functioning at the second visit, maximum 6 month after first visit. Measurements of auditory functioning through hearing assessment (audiometry) : Evaluation of transient otoacoustic emissions (TEOAE) or by distortion product (DPOAE)
Emotional functioning (Auditory recognition of emotions) at the second visit, maximum 6 month after first visit. Measures of Auditory recognition of emotions using hearing tests with recordings
Emotional functioning (anxiety and depression) at the second visit, maximum 6 month after first visit. Measures of Anxiety and Depression using: Hospital Anxiety and Depression Scale (HADS) : 14 rated items from 0 to 3. Seven questions are related to anxiety and seven to the depressive dimension, allowing for thus obtaining two scores (maximum score of each score = 21).
cognitive functioning, other than executive functioning (attention, memory) at the second visit, maximum 6 month after first visit. Measures of cognitive functioning :
- Episodic memory score in auditory modality. The episodic memory test in auditory mode gives a memorization score ranging from 0 to 100, where 100% represents a perfect memorization score.the reorganization of functional and structural brain connectivity maps at the third visit, maximum 18 month after the first visit Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) :
- Measurement of the amplitude of the synchrony of slow fluctuations and statistical dependencies in functional connectivity by comparing data from people with and without chronic tinnitus.Emotional functioning (stress) at the second visit, maximum 6 month after first visit. Measures of stress using Perceived Stress Scale (PSS-4): Lowest score: 0, Highest score: 16, Higher scores are correlated to more stress.
Trial Locations
- Locations (2)
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences
🇫🇷Paris, France