Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete acoustics tests and questionnaires measuring cognitive, emotional, and auditory functions.
1 visit (in-person)
Duration - 1 day
Participants undergo anatomical and functional MRI to examine brain structure and connectivity.
1 visit (in-person) within 6 months after baseline
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
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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