Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of severe or profound deafness, uni or bilateral.
Under legal protection (guardianship, curators, etc.)
MRI contraindicated or claustrophobic
Pregnant or breastfeeding woman.
Trial design
Design model
Parallel
Treatments tested in this trial
acoustics tests, Questionaries,
Other interventionacoustics tests at V1 Questionaries at V1 * cognitive * emotional * auditory
MRI
RadiationAnatomical and functional MRI at V2
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: impact of tinnitus on executive cognitive functioningExperimental treatment 1 intervention
Group B: impact of tinnitus on reorganization of functional/ structural brain connectivity mapsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Evaluation of the impact of tinnitus on executive cognitive functioning
Measurement of executive control using a stroop test in people with and without chronic tinnitus.
Time frame
at the second visit, maximum 6 month after first visit.Secondary outcomes
1
Emotional functioning (anxiety and depression)
Measures of Anxiety and Depression using: Hospital Anxiety and Depression Scale (HADS) : 14 rated items from 0 to 3. Seven questions are related to anxiety and seven to the depressive dimension, allowing for thus obtaining two scores (maximum score of each score = 21).
Time frame
at the second visit, maximum 6 month after first visit.2
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) : \- Self-assessment questionnaires for hearing loss: The self-assessment of hearing loss is based on a yes/no question: "Do you feel that you have a hearing loss or hearing loss?
Time frame
at the second visit, maximum 6 month after first visit.3
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) : \- The noise hypersensitivity questionnaire( Khalfa, 2002) provides a score ranging from 0 (no hypersensitivity) to 42 (very strong hypersensitivity).
Time frame
at the second visit, maximum 6 month after first visit.4
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) : \- The severity of tinnitus is measured by the Tinnitus Handicap Inventory (THI) questionnaire. Scores range from 0 (mild discomfort) to 100 (catastrophic impact).
Time frame
at the second visit, maximum 6 month after first visit.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov