TinnitusAudiCogNCT04717388
Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
A study testing acoustics tests, Questionaries, and MRI in people with Tinnitus and Epilepsy, Temporal Lobe, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Epilepsy, Temporal Lobe
- What is being tested?
- acoustics tests, Questionaries, and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jun 2021to 15 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Service de Soins de Suite et Réadaptation (SSR) Neurologique, DMU de Neurosciences
Paris, 75013
Sophie DUPONT, MD, Ph.D, 01 42 16 03 01, sophie.dupont@aphp.fr
Séverine Samson, Ph.D, 03 20 41 64 43, severine.samson@univ-lille.fr
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Alain LONDERO, 01 56 09 34 79, alain.londero@aphp.fr
About this study
Official title: Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus
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).
Read the 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.
- Conditions
- Tinnitus, Epilepsy, Temporal Lobe
- Being tested
- acoustics tests, Questionaries,, MRI
- Keywords
- Tinnitus, Epilepsy, Cognitive Functioning, Brain connectivity
- Medical subject headings
- Tinnitus, Epilepsy, Temporal Lobe, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoustics tests, Questionaries,Other
acoustics tests at V1 Questionaries at V1
- cognitive
- emotional
- auditory
MRIRadiation
Anatomical and functional MRI at V2
| Study group | Role | What they receive |
|---|---|---|
| impact of tinnitus on executive cognitive functioning | Experimental | Not described Receives: Other: acoustics tests, Questionaries, |
| impact of tinnitus on reorganization of functional/ structural brain connectivity maps | Experimental | Not described Receives: Other: acoustics tests, Questionaries,; Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the second visit, maximum 6 month after first visit.
Secondary outcomes (18)
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).
Measured: at the second visit, maximum 6 month after first visit.
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?
Measured: at the second visit, maximum 6 month after first visit.
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).
Measured: at the second visit, maximum 6 month after first visit.
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).
Measured: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) :
- Hearing threshold measurement (pure tones from 125-16000Hz)
Measured: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) :
- Discomfort threshold measurement (with 1kHz sound)
Measured: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Measurements of auditory functioning through hearing assessment (audiometry) : Evaluation of transient otoacoustic emissions (TEOAE) or by distortion product (DPOAE)
Measured: at the second visit, maximum 6 month after first visit.
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.
Measured: at the second visit, maximum 6 month after first visit.
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.
Measured: at the second visit, maximum 6 month after first visit.
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
Measured: at the second visit, maximum 6 month after first visit.
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.
Measured: at the second visit, maximum 6 month after first visit.
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.
Measured: at the second visit, maximum 6 month after first visit.
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)
Measured: at the third visit, maximum 18 month after the first visit
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).
Measured: at the third visit, maximum 18 month after the first visit
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
Measured: at the third visit, maximum 18 month after the first visit
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.
Measured: at the third visit, maximum 18 month after the first visit
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.
Measured: at the second visit, maximum 6 month after first visit.
Emotional functioning (Auditory recognition of emotions)
Measures of Auditory recognition of emotions using hearing tests with recordings
Measured: at the second visit, maximum 6 month after first visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 Jun 2021
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Dupont, MD, Ph.D, Study director, AP-HP Hopital Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717388
- Sponsor's protocol ID
- APHP200761
- Acronym
- AudiCog
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2020
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus
- ClinicalTrials.gov ID
- NCT04717388
- Acronym / sponsor ID
- AudiCog / APHP200761
- Conditions
- Tinnitus, Epilepsy, Temporal Lobe
- Keywords
- Tinnitus, Epilepsy, Cognitive Functioning, Brain connectivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| impact of tinnitus on executive cognitive functioning | Experimental | Other: acoustics tests, Questionaries, |
| impact of tinnitus on reorganization of functional/ structural brain connectivity maps | Experimental | Other: acoustics tests, Questionaries,, Radiation: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Presence of severe or profound deafness, uni or bilateral.
- Under legal protection (guardianship, curators, etc.)
- MRI contraindicated or claustrophobic
- Pregnant or breastfeeding woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acoustics tests, Questionaries,acoustics tests at V1 Questionaries at V1 * cognitive * emotional * auditory | Other | impact of tinnitus on executive cognitive functioning, impact of tinnitus on reorganization of functional/ structural brain connectivity maps |
| MRIAnatomical and functional MRI at V2 | Radiation | impact of tinnitus on reorganization of functional/ structural brain connectivity maps |
Primary outcome
Evaluation of the impact of tinnitus on executive cognitive functioning
Time frame: at the second visit, maximum 6 month after first visit.
Measurement of executive control using a stroop test in people with and without chronic tinnitus.
18 secondary outcomes
Emotional functioning (anxiety and depression)
Time frame: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Time frame: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Time frame: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Time frame: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Time frame: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Time frame: at the second visit, maximum 6 month after first visit.
psycho-acoustic functioning
Time frame: at the second visit, maximum 6 month after first visit.
cognitive functioning, other than executive functioning (attention, memory)
Time frame: at the second visit, maximum 6 month after first visit.
cognitive functioning, other than executive functioning (attention, memory)
Time frame: at the second visit, maximum 6 month after first visit.
cognitive functioning, other than executive functioning (attention, memory)
Time frame: at the second visit, maximum 6 month after first visit.
cognitive functioning, other than executive functioning (attention, memory)
Time frame: at the second visit, maximum 6 month after first visit.
cognitive functioning, other than executive functioning (attention, memory)
Time frame: at the second visit, maximum 6 month after first visit.
the reorganization of functional and structural brain connectivity maps
Time frame: at the third visit, maximum 18 month after the first visit
the reorganization of functional and structural brain connectivity maps
Time frame: at the third visit, maximum 18 month after the first visit
the reorganization of functional and structural brain connectivity maps
Time frame: at the third visit, maximum 18 month after the first visit
the reorganization of functional and structural brain connectivity maps
Time frame: at the third visit, maximum 18 month after the first visit
Emotional functioning (stress)
Time frame: at the second visit, maximum 6 month after first visit.
Emotional functioning (Auditory recognition of emotions)
Time frame: at the second visit, maximum 6 month after first visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Dupont, MD, Ph.D study director
AP-HP Hopital Pitié-Salpêtrière
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acoustics tests, Questionaries, and MRI in people with Tinnitus and Epilepsy, Temporal Lobe, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie DUPONT, MD, Ph.D (01 42 16 03 01, sophie.dupont@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of tinnitus on executive cognitive functioning (time frame: at the second visit, maximum 6 month after first visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.