NCT04717388Recruiting
Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 15 Dec 2020
- Start date
- 15 Jun 2021
- Primary completion date
- 15 Oct 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Epilepsy
- NCT number
- NCT04717388
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 15 Jun 2021 to the primary completion date, 15 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Criteria the registry did not label
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.