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Recruiting Not applicable

Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus

NCT04717388 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-06-15
Last updated
2024-12-12

Condition(s) studied

TinnitusEpilepsy, Temporal Lobe

Investigational drug(s) / intervention(s)

acoustics tests, Questionaries,MRI

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

MRI: Anatomical and functional MRI at V2

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Common Criteria for Inclusion : * 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 Group Specific Inclusion Criteria : 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.

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences Paris France Recruiting
Hôpital Européen Georges Pompidou Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04717388 on ClinicalTrials.gov ↗ ← All trials in France