Hearing DisorderNCT00359931
Brain Imaging of Tinnitus
An observational study of Hearing Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial summary
This study will use magnetic resonance imaging (MRI) to compare brain function in three groups of people: hearing-impaired people with tinnitus; hearing-impaired people without tinnitus; and people with normal hearing and without tinnitus. Also known as "ringing in the ears," tinnitus is the false sensation of sounds. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Hearing Disorder
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2006to 7 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plus Tinnitus Plus Hearing loss subjects.
- Adults, between the ages of 30 to 65 years.
- Are able to hear and perceive sounds used in the experiment in the range 250 Hz to 2 KHz and have high-frequency sensorineural hearing loss beginning no lower than 2 KHz.
- In good health and not currently taking certain medications regularly (e.g. antidepressants, antiseizure medications, antipsychotics, etc.).
- Experience tinnitus daily.
- Have had non-pulsatile tinnitus for at least 1 year.
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- Have bilateral or bilateral with unilateral dominance tinnitus.
- Minus Tinnitus Plus Hearing loss subjects.
- Adults, between the ages of 30 to 65 years.
- Are able to hear and perceive sounds used in the experiment in the range 250 Hz to 2 KHz and have high-frequency sensorineural hearing loss beginning no lower than 2 KHz.
- In good health and not currently taking certain medications regularly (e.g. antidepressants, antiseizure medications, antipsychotics, etc.).
- Have never or rarely (i.e. transient episodes experienced by virtually everyone) experienced tinnitus.
- Minus Tinnitus Minus Hearing loss subjects or normal volunteers.
- Adults, between the ages of 30 to 65 years.
- Have normal hearing.
- In good health and not currently taking certain medications regularly (e.g. antidepressants, antiseizure medications, antipsychotics, etc.).
Who cannot join
- Subjects who have pacemakers, aneurysm clips, metallic prostheses or shrapnel fragments.
- Subjects incapable of giving informed consent.
- Subjects with a positive pregnancy test.
- Children below the age of 18 years.
- Subjects with hyperacusis or misophonia (hyper-sensitivity to loud noises).
- Subjects with mood disturbances such as depression or anxiety.
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- Subjects with a history of temporomandibular joint problems or who present symptoms of pain and tenderness of the temporomandibular joint on examination.
- Subjects may be excluded for the following reasons that may cause difficulty with interpretation of the imaging data:
- Subjects with mental or physical illnesses, other than tinnitus that may cause problems with participation in the study.
- Subjects with current uncontrolled hypertension, or significant past history of cardiovascular disease and diabetes melitus.
- Subjects with a history of head trauma with loss of consciousness, epilepsy, seizures, a history of chemotherapy (neurotoxic or ototoxic) and other medical conditions that may alter cerebral functioning.
- Subjects who are taking or have a history of taking recreational drugs or alcoholism.
- Subjects with unilateral or asymmetrical hearing loss who have not had (or cannot provide documentation of) comprehensive neuro-otologic workup will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Neural Modeling and Brain Imaging of Tinnitus
This study will use magnetic resonance imaging (MRI) to compare brain function in three groups of people: hearing-impaired people with tinnitus; hearing-impaired people without tinnitus; and people with normal hearing and without tinnitus. Also known as "ringing in the ears," tinnitus is the false sensation of sounds.
Adults between 30 and 65 years of age who meet the following criteria may be eligible for this study:
Read more
- Mild to moderate hearing loss who have experienced tinnitus daily for at least 1 year
- Mild to moderate hearing loss who have never or rarely experienced tinnitus
- Normal hearing who have never or rarely experienced tinnitus
Candidates are screened with a medical history and questionnaires.
Participants have a detailed hearing test to measure hearing and the nature of tinnitus. In a second visit, subjects have a brief physical examination, followed by MRI scanning. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The subject may be asked to lie still for up to 8 minutes at a time. During the MRI, the subject performs computer-based tasks that involve listening to sounds. Another hearing test is done after the MRI.
Read the detailed description
Subjective tinnitus, the false perception of sound in the absence of an acoustic stimulus, occurs frequently as a consequence of noise-induced deafness. The purpose of this study is to investigate the brain sites and mechanisms underlying tinnitus using a combined mathematical modeling and functional brain imaging experimental approach. Although studies have focused on the neural bases of tinnitus, it is not known why tinnitus arises only in certain cases of hearing loss, and the contribution of different brain regions in tinnitus perception is poorly understood. This in turn, prevents the development of better studies and new treatment methods for tinnitus. The primary hypothesis is that a network of brain regions, from auditory processing areas to emotional processing areas, contributes to, and modulates, tinnitus perception. The brain imaging study will be used to study differences in the network of brain regions involved in listening and discriminating sounds for tinnitus sufferers as compared to a control group of subjects with similar hearing loss but without tinnitus. This comparison should permit the identification of brain regions most active in tinnitus. An age matched control group without hearing loss and tinnitus will be included to determine those effects due to hearing loss alone. The mathematical computational modeling will use a previously developed large-scale neural network model of auditory processing in the cerebral cortex, which will be modified to induce tinnitus via different neural mechanisms. The modeling study should allow us to evaluate the contribution of different cortical regions and mechanisms to tinnitus perception; some changes in the model will be more successful than others in inducing tinnitus and in matching simulated brain imaging data with experimental brain imaging data. The modeling study will use the same stimuli and experimental paradigm as the functional brain imaging study. Comparing the experimental and modeling results will provide hypotheses about the most likely mechanism mediating tinnitus. Together, the modeling and experimental studies will advance our knowledge of the brain regions and mechanisms underlying tinnitus.
- Conditions
- Hearing Disorder
- Keywords
- Neural Networks, Mathematical Modeling, Auditory Processing, Tinnitis, Hearing Loss
- Medical subject headings
- Hearing Disorders, Hearing Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary hypothesis is that a network of brain regions, from auditory processing areas to emotional processing areas, contributes to, and modulates, tinnitus perception.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2006 (estimated)
- Study start28 Jul 2006
- Study completion7 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barry Horwitz, Ph.D., Principal investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359931
- Sponsor's protocol ID
- 060218
- Other IDs
- 06-DC-0218
- Status last verified
- 7 Mar 2016
- First submitted
- 2 Aug 2006
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Mirz F, Gjedde A, Sodkilde-Jrgensen H, Pedersen CB. Functional brain imaging of tinnitus-like perception induced by aversive auditory stimuli. Neuroreport. 2000 Feb 28;11(3):633-7. doi: 10.1097/00001756-200002280-00039.
PubMed 10718327Giraud AL, Chery-Croze S, Fischer G, Fischer C, Vighetto A, Gregoire MC, Lavenne F, Collet L. A selective imaging of tinnitus. Neuroreport. 1999 Jan 18;10(1):1-5. doi: 10.1097/00001756-199901180-00001.
PubMed 10094123Mirz F, Gjedde A, Ishizu K, Pedersen CB. Cortical networks subserving the perception of tinnitus--a PET study. Acta Otolaryngol Suppl. 2000;543:241-3. doi: 10.1080/000164800454503.
PubMed 10909031
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Modeling and Brain Imaging of Tinnitus
- ClinicalTrials.gov ID
- NCT00359931
- Acronym / sponsor ID
- 060218
- Conditions
- Hearing Disorder
- Keywords
- Neural Networks, Mathematical Modeling, Auditory Processing, Tinnitis, Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 28 Jul 2006
- Study completion
- 7 Mar 2016
- First posted
- 3 Aug 2006 (estimated)
- 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.
This study will use magnetic resonance imaging (MRI) to compare brain function in three groups of people: hearing-impaired people with tinnitus; hearing-impaired people without tinnitus; and people with normal hearing and without tinnitus. Also known as "ringing in the ears," tinnitus is the false sensation of sounds.
Adults between 30 and 65 years of age who meet the following criteria may be eligible for this study:
- Mild to moderate hearing loss who have experienced tinnitus daily for at least 1 year
- Mild to moderate hearing loss who have never or rarely experienced tinnitus
- Normal hearing who have never or rarely experienced tinnitus
Candidates are screened with a medical history and questionnaires.
Participants have a detailed hearing test to measure hearing and the nature of tinnitus. In a second visit, subjects have a brief physical examination, followed by MRI scanning. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The subject may be asked to lie still for up to 8 minutes at a time. During the MRI, the subject performs computer-based tasks that involve listening to sounds. Another hearing test is done after the MRI.
Detailed description
Subjective tinnitus, the false perception of sound in the absence of an acoustic stimulus, occurs frequently as a consequence of noise-induced deafness. The purpose of this study is to investigate the brain sites and mechanisms underlying tinnitus using a combined mathematical modeling and functional brain imaging experimental approach. Although studies have focused on the neural bases of tinnitus, it is not known why tinnitus arises only in certain cases of hearing loss, and the contribution of different brain regions in tinnitus perception is poorly understood. This in turn, prevents the development of better studies and new treatment methods for tinnitus. The primary hypothesis is that a network of brain regions, from auditory processing areas to emotional processing areas, contributes to, and modulates, tinnitus perception. The brain imaging study will be used to study differences in the network of brain regions involved in listening and discriminating sounds for tinnitus sufferers as compared to a control group of subjects with similar hearing loss but without tinnitus. This comparison should permit the identification of brain regions most active in tinnitus. An age matched control group without hearing loss and tinnitus will be included to determine those effects due to hearing loss alone. The mathematical computational modeling will use a previously developed large-scale neural network model of auditory processing in the cerebral cortex, which will be modified to induce tinnitus via different neural mechanisms. The modeling study should allow us to evaluate the contribution of different cortical regions and mechanisms to tinnitus perception; some changes in the model will be more successful than others in inducing tinnitus and in matching simulated brain imaging data with experimental brain imaging data. The modeling study will use the same stimuli and experimental paradigm as the functional brain imaging study. Comparing the experimental and modeling results will provide hypotheses about the most likely mechanism mediating tinnitus. Together, the modeling and experimental studies will advance our knowledge of the brain regions and mechanisms underlying tinnitus.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Plus Tinnitus Plus Hearing loss subjects.
- Adults, between the ages of 30 to 65 years.
- Are able to hear and perceive sounds used in the experiment in the range 250 Hz to 2 KHz and have high-frequency sensorineural hearing loss beginning no lower than 2 KHz.
- In good health and not currently taking certain medications regularly (e.g. antidepressants, antiseizure medications, antipsychotics, etc.).
- Experience tinnitus daily.
Key exclusion criteria (13 listed)
- Subjects who have pacemakers, aneurysm clips, metallic prostheses or shrapnel fragments.
- Subjects incapable of giving informed consent.
- Subjects with a positive pregnancy test.
- Children below the age of 18 years.
- Subjects with hyperacusis or misophonia (hyper-sensitivity to loud noises).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary hypothesis is that a network of brain regions, from auditory processing areas to emotional processing areas, contributes to, and modulates, tinnitus perception.
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 10718327Mirz F, Gjedde A, Sodkilde-Jrgensen H, Pedersen CB. Functional brain imaging of tinnitus-like perception induced by aversive auditory stimuli. Neuroreport. 2000 Feb 28;11(3):633-7. doi: 10.1097/00001756-200002280-00039.
- Background: PubMed 10094123Giraud AL, Chery-Croze S, Fischer G, Fischer C, Vighetto A, Gregoire MC, Lavenne F, Collet L. A selective imaging of tinnitus. Neuroreport. 1999 Jan 18;10(1):1-5. doi: 10.1097/00001756-199901180-00001.
- Background: PubMed 10909031Mirz F, Gjedde A, Ishizu K, Pedersen CB. Cortical networks subserving the perception of tinnitus--a PET study. Acta Otolaryngol Suppl. 2000;543:241-3. doi: 10.1080/000164800454503.
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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. This study is not recruiting at the moment.
Barry Horwitz, Ph.D. principal investigator
National Institute on Deafness and Other Communication Disorders (NIDCD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
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 16 inclusion and 13 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: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary hypothesis is that a network of brain regions, from auditory processing areas to emotional processing areas, contributes to, and modulates, tinnitus perception. (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00359931, which also lists 3 linked publications.
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 6 Oct 2017.