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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04717388
Other study ID # APHP200761
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2021
Est. completion date April 15, 2026

Study information

Verified date February 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Sophie DUPONT, MD, Ph.D
Phone 01 42 16 03 01
Email sophie.dupont@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
acoustics tests, Questionaries,
acoustics tests at V1 Questionaries at V1 cognitive emotional auditory
Radiation:
MRI
Anatomical and functional MRI at V2

Locations

Country Name City State
France Hôpital Européen Georges Pompidou Paris
France Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at the second visit, maximum 6 month after first visit.
Secondary 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). at the second visit, maximum 6 month after first visit.
Secondary 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?
at the second visit, maximum 6 month after first visit.
Secondary 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).
at the second visit, maximum 6 month after first visit.
Secondary 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).
at the second visit, maximum 6 month after first visit.
Secondary psycho-acoustic functioning Measurements of auditory functioning through hearing assessment (audiometry) :
- Hearing threshold measurement (pure tones from 125-16000Hz)
at the second visit, maximum 6 month after first visit.
Secondary psycho-acoustic functioning Measurements of auditory functioning through hearing assessment (audiometry) :
- Discomfort threshold measurement (with 1kHz sound)
at the second visit, maximum 6 month after first visit.
Secondary psycho-acoustic functioning Measurements of auditory functioning through hearing assessment (audiometry) : Evaluation of transient otoacoustic emissions (TEOAE) or by distortion product (DPOAE) at the second visit, maximum 6 month after first visit.
Secondary cognitive functioning, other than executive functioning (attention, memory) Measures of cognitive functioning :
- the Attentional Network Test (ANT) visual attention test.
ANT gives three attention scores based on reaction times. These scores represent the ability to direct attention, to be alert to surrounding stimuli and the executive part of attention.
at the second visit, maximum 6 month after first visit.
Secondary cognitive functioning, other than executive functioning (attention, memory) Measures of cognitive functioning :
- Mental Flexibility Score (Trail Making Test): The scores of the TMT (Trail Making Test) are expressed in time of completion. The faster the time to completion, the better the performance. So we have 2 scores, one for board A of the test: TMT-A and the other for board B of the test: TMT-B.
at the second visit, maximum 6 month after first visit.
Secondary cognitive functioning, other than executive functioning (attention, memory) Measures of cognitive functioning :
Measures of cognitive functioning :- Short-term memory score (auditive-verbal span). Score between 1 and 10, where 10 represents the best short-term memory score
at the second visit, maximum 6 month after first visit.
Secondary cognitive functioning, other than executive functioning (attention, memory) Measures of cognitive functioning :
Measures of cognitive functioning :- Working memory score (Brown-Peterson). The Brown Peterson gives a memorization score ranging from 0 to 100, where 100% is the best score.
at the second visit, maximum 6 month after first visit.
Secondary cognitive functioning, other than executive functioning (attention, memory) Measures of cognitive functioning :
- Episodic memory score in auditory modality. The episodic memory test in auditory mode gives a memorization score ranging from 0 to 100, where 100% represents a perfect memorization score.
at the second visit, maximum 6 month after first visit.
Secondary the reorganization of functional and structural brain connectivity maps Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) :
- Volumetric measurement (in particular of the amygdala and the parahippocampal cortex)
at the third visit, maximum 18 month after the first visit
Secondary the reorganization of functional and structural brain connectivity maps Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) :
- Measurement of anatomical connections between regions of interest (i.e. amygdala, auditory cortex, attention network including the precuneus and prefrontal cortex) from diffusion tensor imaging (TDI): fractional anisotropy (FA), mean diffusivity (MD), radial (RD) and axial (AD).
at the third visit, maximum 18 month after the first visit
Secondary the reorganization of functional and structural brain connectivity maps Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) :
- Measurement of structural connectivity from fMRI at rest between predefined regions of interest and over new regions of interest defined during an attentional activation task
at the third visit, maximum 18 month after the first visit
Secondary the reorganization of functional and structural brain connectivity maps Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) :
- Measurement of the amplitude of the synchrony of slow fluctuations and statistical dependencies in functional connectivity by comparing data from people with and without chronic tinnitus.
at the third visit, maximum 18 month after the first visit
Secondary Emotional functioning (stress) Measures of stress using Perceived Stress Scale (PSS-4): Lowest score: 0, Highest score: 16, Higher scores are correlated to more stress. at the second visit, maximum 6 month after first visit.
Secondary Emotional functioning (Auditory recognition of emotions) Measures of Auditory recognition of emotions using hearing tests with recordings at the second visit, maximum 6 month after first visit.
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