MedDataX Logo

Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus

NCT ID: NCT04717388

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2029-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tinnitus Epilepsy, Temporal Lobe

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tinnitus Epilepsy Cognitive Functioning Brain connectivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

impact of tinnitus on executive cognitive functioning

Group Type EXPERIMENTAL

acoustics tests, Questionaries,

Intervention Type OTHER

acoustics tests at V1 Questionaries at V1

* cognitive
* emotional
* auditory

impact of tinnitus on reorganization of functional/ structural brain connectivity maps

Group Type EXPERIMENTAL

acoustics tests, Questionaries,

Intervention Type OTHER

acoustics tests at V1 Questionaries at V1

* cognitive
* emotional
* auditory

MRI

Intervention Type RADIATION

Anatomical and functional MRI at V2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acoustics tests, Questionaries,

acoustics tests at V1 Questionaries at V1

* cognitive
* emotional
* auditory

Intervention Type OTHER

MRI

Anatomical and functional MRI at V2

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sophie Dupont, MD, Ph.D

Role: STUDY_DIRECTOR

AP-HP Hopital Pitié-Salpêtrière

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences

Paris, , France

Site Status RECRUITING

Hôpital Européen Georges Pompidou

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sophie DUPONT, MD, Ph.D

Role: CONTACT

Phone: 01 42 16 03 01

Email: [email protected]

Séverine Samson, Ph.D

Role: CONTACT

Phone: 03 20 41 64 43

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sophie DUPONT, MD, Ph.D

Role: primary

Séverine Samson, Ph.D

Role: backup

Alain LONDERO

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

APHP200761

Identifier Type: -

Identifier Source: org_study_id