Understanding the effects of tinnitus on cognitive and emotional functioning in patients with epilepsy
Official title: Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus
Run by Assistance Publique - Hôpitaux de Paris · NCT04717388 · Data updated 2026-11-12
This study is trying to see how tinnitus affects thinking and emotions in people with epilepsy who have had surgery, by comparing those with tinnitus to those without.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Status | Recruiting |
| Started | June 15, 2021 |
| Main results expected | October 15, 2027 |
| Study ends | April 15, 2029 |
| Registry record updated | December 12, 2024 |
| Trial ID | NCT04717388 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with chronic tinnitus or those who have undergone surgery for drug-resistant temporal lobe epilepsy.
✕Probably not a fit
Patients with severe or profound deafness or those with pre-existing neurological disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the relationship between tinnitus and cognitive, emotional, and psychoacoustic functioning in patients who have undergone surgery for drug-resistant temporal lobe epilepsy. It aims to clarify the pathophysiology of tinnitus by comparing individuals with tinnitus to matched tinnitus-free groups. The methodology includes acoustic tests, questionnaires, and MRI assessments to gather comprehensive data on the impact of tinnitus. The research seeks to fill gaps in knowledge regarding the neurobiological and psychological aspects of tinnitus.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of tinnitus, enhancing the quality of life for affected patients.
How similar studies have gone: While there is ongoing research into tinnitus, this study presents a novel approach by focusing on the specific population of surgical epilepsy patients and their unique vulnerabilities to tinnitus.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences
Paris, France Recruiting -
Hôpital Européen Georges Pompidou
Paris, France Recruiting
Study contacts
- Study coordinator: Sophie DUPONT, MD, Ph.D
- Email: sophie.dupont@aphp.fr
- Phone: 01 42 16 03 01
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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DeepTMS for chronic tinnitus using different H-coils
This study tests whether deep repetitive transcranial magnetic stimulation with different H-coils can reduce tinnitus distress in adults with chronic tinnitus, compared to placebo.
-
Non-Invasive Neurofeedback for Tinnitus Distress
This trial tests whether real-time neurofeedback training can reduce distress from tinnitus in adults with bothersome symptoms.
-
TRTL-913 in adults with tinnitus: safety and signals of benefit
This trial tests TRTL-913 versus placebo in healthy adults and in adults with tinnitus to see if it is safe, tolerable, and potentially helpful for tinnitus patients.
-
Foot reflexology or ta-VNS for tinnitus in adults
This trial tests whether foot reflexology, left-ear vagus nerve stimulation, or auricular acupressure can help reduce tinnitus symptoms in adults with tinnitus.
-
Spatial scene memory testing for people with temporal lobe epilepsy having surgery
This project tests whether a virtual tour memory task combined with brain recordings can show how adults with temporal lobe epilepsy recognize and recall places.
-
Mild 8 dB hearing amplification for tinnitus in adults with normal hearing
This test tries wearing hearing aids that add a small (8 dB) boost to see if they reduce tinnitus symptoms in adults with normal hearing.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.