Understanding the effects of tinnitus on cognitive and emotional functioning in patients with epilepsy
Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT04717388 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe or profound deafness or those with pre-existing neurological disorders may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.