Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04717388

Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-12

300

Participants Needed

2

Research Sites

408 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �38 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
  • Suffering from subjective uni- or bilateral tinnitus, chronic (>3 months) and stable (no period of remission) for Tinnitus+ Group
  • Surgically treated for drug-resistant epilepsy of the temporal lobe (including the amygdala) for Chir+ Group
  • Not suffering from tinnitus for Group Tinnitus-
  • Non epileptic for Group Chir-
  • Not having undergone surgical treatment of the temporal lobe (including the tonsil) for Group Chir-
Not Eligible

You will not qualify if you...

  • Presence of severe or profound deafness, uni or bilateral
  • Under legal protection (guardianship, curators, etc.)
  • MRI contraindicated or claustrophobic for patients completing visit V2
  • Pregnant or breastfeeding woman for patients completing visit V2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

Paris, France, 75013

Actively Recruiting

2

Hôpital Européen Georges Pompidou

Paris, France, 75015

Actively Recruiting

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Research Team

S

Sophie DUPONT, MD, Ph.D

CONTACT

S

Séverine Samson, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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