Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04717388

Cognitive and Emotional Function and Brain Reorganisation Associated with Auditory Abilities: Impact of Tinnitus

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

300

Participants Needed

2

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying tinnitus, a condition characterized by ringing in the ears, particularly focusing on its impact on cognitive, emotional, psychoacoustic, and brain functions. This study explores tinnitus in patients who have had brain surgery for drug-resistant temporal lobe epilepsy and compares them to other tinnitus sufferers and control groups without tinnitus. The goal is to better understand brain changes and the psychological and hearing effects linked to tinnitus using this new clinical model. Participants undergo various assessments over multiple visits. These include acoustic tests and questionnaires about cognitive, emotional, and auditory functions at the first visit, followed by anatomical and functional MRI scans at the second visit. The study compares different groups based on tinnitus presence and history of temporal lobe surgery, aiming to clarify how tinnitus relates to brain network reorganization. During the study, participants complete evaluations of executive cognitive function, emotional states like anxiety and depression, psychoacoustic measurements, and other cognitive functions such as attention and memory. Brain connectivity changes are assessed up to 18 months after the first visit. The study monitors these aspects through structured visits and collects data to understand the broader effects of tinnitus on brain and behavior.

CONDITIONS

Brief 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 18 years or older
  • Good written and oral comprehension of the French language
  • Affiliated with a Social Security scheme
  • Signed informed consent
  • Normal or corrected vision
  • No known pre-existing neurological or degenerative disorders
  • Suffering from subjective uni- or bilateral tinnitus, chronic (>3 months) and stable (no remission) for the Tinnitus+ group
  • Surgically treated for drug-resistant temporal lobe epilepsy (including the amygdala) for the Chir+ group
  • No tinnitus and non-epileptic, and no prior surgical treatment of the temporal lobe for the Tinnitus- and Chir- groups
Not Eligible

You will not qualify if you...

  • Presence of severe or profound deafness, unilateral or bilateral
  • Under legal protection (guardianship, curatorship, etc.)
  • MRI contraindicated or claustrophobic for patients completing the second visit
  • Pregnant or breastfeeding women for patients completing the second visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessments

Duration - 1 day

Participants complete acoustics tests and questionnaires measuring cognitive, emotional, and auditory functions.

1 visit (in-person)

MRI Assessment

Duration - 1 day

Participants undergo anatomical and functional MRI to examine brain structure and connectivity.

1 visit (in-person) within 6 months after baseline

Long-term Monitoring

Duration - Up to 18 months after the first visit

Participants are observed for changes in brain connectivity and functional reorganization related to tinnitus.

1 visit (in-person) within 18 months after baseline

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

S

Séverine Samson, Ph.D

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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