Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus

NCT04717388 | Recruiting

• 1 other identifier: APHP200761
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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).

Conditions

Tinnitus; Epilepsy, Temporal Lobe

Keywords

Tinnitus; Epilepsy; Cognitive Functioning; Brain connectivity

Outcome Measures

Primary Outcomes (1)

• Evaluation of the impact of tinnitus on executive cognitive functioning

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

  at the second visit, maximum 6 month after first visit.

Secondary Outcomes (18)

• Emotional functioning (anxiety and depression)

  at the second visit, maximum 6 month after first visit.

• psycho-acoustic functioning

  at the second visit, maximum 6 month after first visit.

• psycho-acoustic functioning

  at the second visit, maximum 6 month after first visit.

• psycho-acoustic functioning

  at the second visit, maximum 6 month after first visit.

• psycho-acoustic functioning

  at the second visit, maximum 6 month after first visit.

Study Arms (2)

impact of tinnitus on executive cognitive functioning

EXPERIMENTAL

Other: acoustics tests, Questionaries,

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

EXPERIMENTAL

Other: acoustics tests, Questionaries,; Radiation: MRI

Interventions

acoustics tests, Questionaries, OTHER

acoustics tests at V1 Questionaries at V1 * cognitive * emotional * auditory

impact of tinnitus on executive cognitive functioning; impact of tinnitus on reorganization of functional/ structural brain connectivity maps

MRI RADIATION

Anatomical and functional MRI at V2

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

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

Paris, 75013, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Tinnitus; Epilepsy, Temporal Lobe; Epilepsy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Epileptic Syndromes

Study Officials

• Sophie Dupont, MD, Ph.D

  AP-HP Hopital Pitié-Salpêtrière

  STUDY DIRECTOR

Central Study Contacts

Sophie DUPONT, MD, Ph.D

CONTACT

01 42 16 03 01; sophie.dupont@aphp.fr

Séverine Samson, Ph.D

CONTACT

03 20 41 64 43; severine.samson@univ-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 22, 2021
• Study Start: June 15, 2021
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): April 15, 2029
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)