Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus (AudiCog)
Primary Purpose
Tinnitus, Epilepsy, Temporal Lobe
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
acoustics tests, Questionaries,
MRI
Sponsored by
About this trial
This is an interventional other trial for Tinnitus focused on measuring Tinnitus, Epilepsy, Cognitive Functioning, Brain connectivity
Eligibility 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.
Sites / Locations
- Hôpital Pitié-Salpêtrière
- Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de NeurosciencesRecruiting
- Hôpital Européen Georges PompidouRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
impact of tinnitus on executive cognitive functioning
impact of tinnitus on reorganization of functional/ structural brain connectivity maps
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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?
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).
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).
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) :
- Hearing threshold measurement (pure tones from 125-16000Hz)
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) :
- Discomfort threshold measurement (with 1kHz sound)
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) : Evaluation of transient otoacoustic emissions (TEOAE) or by distortion product (DPOAE)
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.
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.
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
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.
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.
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)
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).
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
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.
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.
Emotional functioning (Auditory recognition of emotions)
Measures of Auditory recognition of emotions using hearing tests with recordings
Full Information
NCT ID
NCT04717388
First Posted
December 15, 2020
Last Updated
May 15, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04717388
Brief Title
Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
Acronym
AudiCog
Official Title
Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
June 7, 2024 (Anticipated)
Study Completion Date
June 7, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
Tinnitus (known as "ringing in the ears") is a disabling medical condition. Its psychosocial impact is substantial, including anxiety, depression, stress, irritability, concentration and sleep disorder leading to detrimental effects on communication, education, professional fulfillment, mental health and quality of life. The cerebral bases of tinnitus and its consequence on human hearing health have received a lot of attention in the scientific literature. Yet, the relationship between the neurobiological dysfunction, psychological processes and clinical semiology of tinnitus remains poorly understood. Considering the current gaps in knowledge, there is a real need for clinical investigations into tinnitus-related brain changes and rigorous hearing, psycho-emotional, and cognitive assessments. the investigators recent discovery of a vulnerability to tinnitus associated with medial temporal lobe surgery (to treat refractory epilepsy) provides a new clinical model, which targets the temporal lobe regions as a tinnitus generator or mediator of its severity. The goal of this collaborative interdisciplinary study is to advance knowledge about the pathophysiology of tinnitus, as well as the socio-emotional, cognitive and psychoacoustic aspects associated to this hearing disorder. the investigators will first, characterize the subjective and self-reported hearing disorders with objective psychoacoustic, cognitive and affective measures in tinnitus sufferers and second, clarify the cerebral network underlying tinnitus and elucidate the role temporal lobe regions in the brain networks at play in surgical and non-surgical tinnitus. To this end, individuals with and without tinnitus, who had undergone or not a surgery will be compared in a 2 by 2 design. Investigating different patient cohorts with tinnitus who are well matched to both, healthy control populations and vulnerable clinical populations, without tinnitus is a valuable contribution of our proposal. Moreover, the psychological and hearing profiles of people with tinnitus will be examined in relation with their brain morphology and connectivity profiles.The project builds upon the internationally recognized leadership of the PI and her collaborators in the fields of auditory cognition and its neurobiological bases using neuropsychological, psychoacoustic, and neuroimaging methods in clinical populations. The members of the investigators consortium have all the necessary and unique expertise to carry out this innovative and interdisciplinary project.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Epilepsy, Temporal Lobe
Keywords
Tinnitus, Epilepsy, Cognitive Functioning, Brain connectivity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
impact of tinnitus on executive cognitive functioning
Arm Type
Experimental
Arm Title
impact of tinnitus on reorganization of functional/ structural brain connectivity maps
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
acoustics tests, Questionaries,
Intervention Description
acoustics tests at V1 Questionaries at V1
cognitive
emotional
auditory
Intervention Type
Radiation
Intervention Name(s)
MRI
Intervention Description
Anatomical and functional MRI at V2
Primary Outcome Measure Information:
Title
Evaluation of the impact of tinnitus on executive cognitive functioning
Description
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 Outcome Measure Information:
Title
Emotional functioning (anxiety and depression)
Description
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.
Title
psycho-acoustic functioning
Description
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.
Title
psycho-acoustic functioning
Description
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.
Title
psycho-acoustic functioning
Description
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.
Title
psycho-acoustic functioning
Description
Measurements of auditory functioning through hearing assessment (audiometry) :
- Hearing threshold measurement (pure tones from 125-16000Hz)
Time Frame
at the second visit, maximum 6 month after first visit.
Title
psycho-acoustic functioning
Description
Measurements of auditory functioning through hearing assessment (audiometry) :
- Discomfort threshold measurement (with 1kHz sound)
Time Frame
at the second visit, maximum 6 month after first visit.
Title
psycho-acoustic functioning
Description
Measurements of auditory functioning through hearing assessment (audiometry) : Evaluation of transient otoacoustic emissions (TEOAE) or by distortion product (DPOAE)
Time Frame
at the second visit, maximum 6 month after first visit.
Title
cognitive functioning, other than executive functioning (attention, memory)
Description
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.
Time Frame
at the second visit, maximum 6 month after first visit.
Title
cognitive functioning, other than executive functioning (attention, memory)
Description
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.
Time Frame
at the second visit, maximum 6 month after first visit.
Title
cognitive functioning, other than executive functioning (attention, memory)
Description
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
Time Frame
at the second visit, maximum 6 month after first visit.
Title
cognitive functioning, other than executive functioning (attention, memory)
Description
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.
Time Frame
at the second visit, maximum 6 month after first visit.
Title
cognitive functioning, other than executive functioning (attention, memory)
Description
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.
Time Frame
at the second visit, maximum 6 month after first visit.
Title
the reorganization of functional and structural brain connectivity maps
Description
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)
Time Frame
at the third visit, maximum 18 month after the first visit
Title
the reorganization of functional and structural brain connectivity maps
Description
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).
Time Frame
at the third visit, maximum 18 month after the first visit
Title
the reorganization of functional and structural brain connectivity maps
Description
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
Time Frame
at the third visit, maximum 18 month after the first visit
Title
the reorganization of functional and structural brain connectivity maps
Description
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.
Time Frame
at the third visit, maximum 18 month after the first visit
Title
Emotional functioning (stress)
Description
Measures of stress using Perceived Stress Scale (PSS-4): Lowest score: 0, Highest score: 16, Higher scores are correlated to more stress.
Time Frame
at the second visit, maximum 6 month after first visit.
Title
Emotional functioning (Auditory recognition of emotions)
Description
Measures of Auditory recognition of emotions using hearing tests with recordings
Time Frame
at the second visit, maximum 6 month after first visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie DUPONT, MD, Ph.D
Phone
01 42 16 03 01
Email
sophie.dupont@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Séverine Samson, Ph.D
Phone
03 20 41 64 43
Email
severine.samson@univ-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Dupont, MD, Ph.D
Organizational Affiliation
AP-HP Hopital Pitié-Salpêtrière
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent NAVARRO
Phone
01 42 16 18 11
Email
vincent.navarro@aphp.fr
Facility Name
Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie DUPONT, MD, Ph.D
Phone
01 42 16 03 01
Email
sophie.dupont@aphp.fr
First Name & Middle Initial & Last Name & Degree
Séverine Samson, Ph.D
Phone
03 20 41 64 43
Email
severine.samson@univ-lille.fr
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain LONDERO
Phone
01 56 09 34 79
Email
alain.londero@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
We'll reach out to this number within 24 hrs