TinnitusNCT01049828
Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother
An observational study of Tinnitus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Tinnitus is the occurrence of an auditory sensation without the presence of an acoustic stimulus. Approximately, 50 million people in the United States experience chronic tinnitus and 15 million of these people have bothersome tinnitus. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Tinnitus
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 19 adults between the ages of 45 and 60 years, age and hearing level-matched to the bothered tinnitus cohort from the on-going research at Washington University. Subjects will be recruited from an institutional tinnitus database, from Washington University Otolaryngology Clinics, as well as the general public through poster advertisement on the Washington University grounds.
Who may be able to join
- Men and women between the ages of 45 and 60 years
- Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater
- A recent audiogram (within 6 months)
- Either "not bothered" or "bothered a little" on the Global Bothersome scale
- Able to give informed consent
- English-speaking
Who cannot join
- Patients experiencing tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone
- Patients with hyperacusis or misophonia (hyper-sensitivity to loud noises)
- Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, other intracranial metal objects with the exception of dental fillings, or any other contraindication for MRI scan
- Patients with an acute or chronic unstable medical condition which, in the opinion of the investigator, would require stabilization prior to initiation of magnetic stimulation
- Patients with any active ear disease that, in the opinion of the PI, needs to be further evaluated
- Patients with symptoms of depression as evidenced by a score of 14 or greater on the Beck Depression Inventory or, in the opinion of the psychiatric sub-investigator demonstrates active mood symptoms that meet DSM-IV-TR criteria for Major Depressive Disorder
Show all 16Show fewer
- Any psychiatric co-morbidity that, in the opinion of the psychiatric sub-investigator, may complicate the interpretation of study results
- Patients with tinnitus related to Workman's Compensation claim or litigation-related event
- Weight over 350 pounds
- A Mini-Mental Status Exam score less than 27
- Patients with a history of claustrophobia
- Inability to lay flat for 2 hours
- Active alcohol and/or drug dependence or history of alcohol and/or drug dependence within the last year
- Any medical condition that, in the opinion of the investigators, confounds study results or places the subject at greater risk
- Unable to provide informed consent
- Any exclusions from radiology screening Currently Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University, Center for Clinical Studies
St Louis, Missouri, 63110
About this study
Tinnitus is the occurrence of an auditory sensation without the presence of an acoustic stimulus. Approximately, 50 million people in the United States experience chronic tinnitus and 15 million of these people have bothersome tinnitus. Several studies have shown that people who are bothered by their tinnitus have difficulty in concentration and focus. Through imaging modalities we have deranged neural networks responsible for attention. Only 20 percent of patients diagnosed with tinnitus are severely bothered. We seek the following:
- Match a group of non-bothered tinnitus patients on age and hearing status to an existing cohort of bothered tinnitus patients.
- Assess the resting-state neural connectivity in patients with non-bothersome tinnitus. Findings from the comparison of functional connectivity magnetic resonance imaging (fcMRI) from subjects with bothersome tinnitus in our current rTMS clinical trial to normal age-matched controls without tinnitus demonstrates that subjects with bothersome tinnitus have dramatic alterations in cortical attention and control networks. Our hypothesis is that the fcMRI-defined changes in the attention and control networks reflect the impact of excessive auditory stimulation in patients with bothersome tinnitus and explains the difficulty with concentration, short-term memory, and other common problems. To fully test this hypothesis we need to obtain fcMRI of the attention network among subjects with tinnitus but without bother and compare the status of their neural networks with those of tinnitus subjects with bother and with normal controls.
- Compare the resting cortical networks in subjects with non-bothersome tinnitus to subjects with bothersome tinnitus and subjects without tinnitus Our null hypothesis is that there are no differences in the resting-state cortical networks, especially the attention and control networks, between tinnitus patients who do not experience bother, tinnitus patients who do experience bother, and subjects without tinnitus. Through fcMRI, we will examine correlations in blood oxygen level dependent (BOLD) signals in established auditory, attention, control, and other brain regions in the resting brain and compare these findings to already collected fcMRI scans of bothered tinnitus patients, and controls (patients without tinnitus).
- Conditions
- Tinnitus
- Being tested
- No intervention
- Keywords
- Tinnitus, fcMRI, Neural Connectivity, Bother
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No treatment for tinnitus will occur in this study.
| Study group | Role | What they receive |
|---|---|---|
| Slightly or Non-Bothered Tinnitus Group | Identified by a Tinnitus Handicap Index <36 and a subjective description of their tinnitus as no or slight "bother."
A control group has been collected through a different study, i.e. no controls will be recruited in this study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Changes in Blood Oxygen Level as Measured by Functional Connectivity MRI
Perform Functional connectivity MRI on participants with non-bothersome tinnitus. By undergoing a functional MRI, we are able to delineate the various networks involved with tinnitus including the default mode, attention, auditory, visual, somatosensory, and cognitive networks. The functional connectivity differences are measured by changes in blood oxygen level changes.
Measured: 8 months for complete analysis on all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre M Wineland, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049828
- Sponsor's protocol ID
- WU625296
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2010
- Last updated
- 25 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wineland AM, Burton H, Piccirillo J. Functional connectivity networks in nonbothersome tinnitus. Otolaryngol Head Neck Surg. 2012 Nov;147(5):900-6. doi: 10.1177/0194599812451414. Epub 2012 Jun 21.
PubMed 22722065
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother
- ClinicalTrials.gov ID
- NCT01049828
- Acronym / sponsor ID
- WU625296
- Conditions
- Tinnitus
- Keywords
- Tinnitus, fcMRI, Neural Connectivity, Bother
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 25 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tinnitus is the occurrence of an auditory sensation without the presence of an acoustic stimulus. Approximately, 50 million people in the United States experience chronic tinnitus and 15 million of these people have bothersome tinnitus. Several studies have shown that people who are bothered by their tinnitus have difficulty in concentration and focus. Through imaging modalities we have deranged neural networks responsible for attention. Only 20 percent of patients diagnosed with tinnitus are severely bothered. We seek the following:
- Match a group of non-bothered tinnitus patients on age and hearing status to an existing cohort of bothered tinnitus patients.
- Assess the resting-state neural connectivity in patients with non-bothersome tinnitus. Findings from the comparison of functional connectivity magnetic resonance imaging (fcMRI) from subjects with bothersome tinnitus in our current rTMS clinical trial to normal age-matched controls without tinnitus demonstrates that subjects with bothersome tinnitus have dramatic alterations in cortical attention and control networks. Our hypothesis is that the fcMRI-defined changes in the attention and control networks reflect the impact of excessive auditory stimulation in patients with bothersome tinnitus and explains the difficulty with concentration, short-term memory, and other common problems. To fully test this hypothesis we need to obtain fcMRI of the attention network among subjects with tinnitus but without bother and compare the status of their neural networks with those of tinnitus subjects with bother and with normal controls.
- Compare the resting cortical networks in subjects with non-bothersome tinnitus to subjects with bothersome tinnitus and subjects without tinnitus Our null hypothesis is that there are no differences in the resting-state cortical networks, especially the attention and control networks, between tinnitus patients who do not experience bother, tinnitus patients who do experience bother, and subjects without tinnitus. Through fcMRI, we will examine correlations in blood oxygen level dependent (BOLD) signals in established auditory, attention, control, and other brain regions in the resting brain and compare these findings to already collected fcMRI scans of bothered tinnitus patients, and controls (patients without tinnitus).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Slightly or Non-Bothered Tinnitus Group | – | Other: No interventionIdentified by a Tinnitus Handicap Index <36 and a subjective description of their tinnitus as no or slight "bother." A control group has been collected through a different study, i.e. no controls will be recruited in this study. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 19 adults between the ages of 45 and 60 years, age and hearing level-matched to the bothered tinnitus cohort from the on-going research at Washington University. Subjects will be recruited from an institutional tinnitus database, from Washington University Otolaryngology Clinics, as well as the general public through poster advertisement on the Washington University grounds.
Key inclusion criteria (6 listed)
- Men and women between the ages of 45 and 60 years
- Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater
- A recent audiogram (within 6 months)
- Either "not bothered" or "bothered a little" on the Global Bothersome scale
- Able to give informed consent
Key exclusion criteria (16 listed)
- Patients experiencing tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone
- Patients with hyperacusis or misophonia (hyper-sensitivity to loud noises)
- Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, other intracranial metal objects with the exception of dental fillings, or any other contraindication for MRI scan
- Patients with an acute or chronic unstable medical condition which, in the opinion of the investigator, would require stabilization prior to initiation of magnetic stimulation
- Patients with any active ear disease that, in the opinion of the PI, needs to be further evaluated
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 |
|---|---|---|
| No interventionNo treatment for tinnitus will occur in this study. | Other | Slightly or Non-Bothered Tinnitus Group |
Primary outcome
Number of Participants With Changes in Blood Oxygen Level as Measured by Functional Connectivity MRI
Time frame: 8 months for complete analysis on all participants
Perform Functional connectivity MRI on participants with non-bothersome tinnitus. By undergoing a functional MRI, we are able to delineate the various networks involved with tinnitus including the default mode, attention, auditory, visual, somatosensory, and cognitive networks. The functional connectivity differences are measured by changes in blood oxygen level changes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22722065Wineland AM, Burton H, Piccirillo J. Functional connectivity networks in nonbothersome tinnitus. Otolaryngol Head Neck Surg. 2012 Nov;147(5):900-6. doi: 10.1177/0194599812451414. Epub 2012 Jun 21.
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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.
Andre M Wineland, MD principal investigator
Washington University School of Medicine
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 Tinnitus, run by Washington University School of Medicine 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 6 inclusion and 16 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 25 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Changes in Blood Oxygen Level as Measured by Functional Connectivity MRI (time frame: 8 months for complete analysis on all participants). 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 NCT01049828, which also lists 1 linked publication.
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 25 Jul 2024.