Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04717388
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Sophie DUPONT, MD, Ph.D
Phone 01 42 16 03 01
Email sophie.dupont@aphp.fr
Status Recruiting
Phase N/A
Start date June 15, 2021
Completion date April 15, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05963542 - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia N/A
Recruiting NCT04987502 - Virtual Reality and Subjective Tinnitus N/A
Recruiting NCT04404439 - Treatment of Tinnitus With Migraine Medications Phase 4
Recruiting NCT05533840 - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Completed NCT03552302 - Effects of Yoga Exercise on Participates With Tinnitus
Enrolling by invitation NCT02617953 - Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus N/A
Withdrawn NCT01663467 - Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy N/A
Completed NCT02269839 - A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus N/A
Completed NCT02974543 - Somatosensory Stimulation to Alleviate Tinnitus N/A
Completed NCT01929837 - Tinnitus rTMS 2013 N/A
Completed NCT01927991 - Internet-based Self-help for Tinnitus: The Role of Support N/A
Completed NCT01857661 - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial N/A
Terminated NCT01412918 - Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression N/A
Completed NCT01480193 - New Therapy for Patients With Severe Tinnitus N/A
Completed NCT00748475 - Countering Stimulus-Induced Alpha-Desynchronization to Treat Tinnitus N/A
Completed NCT00371436 - Progressive Intervention Program for Tinnitus Management N/A
Completed NCT00733044 - Cost-effectiveness of Multidisciplinary Management of Tinnitus N/A
Active, not recruiting NCT05518682 - Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus N/A
Recruiting NCT05212298 - Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus N/A
Completed NCT06025097 - Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus. Early Phase 1