Tinnitus
Conditions
Keywords
Tinnitus, fcMRI, Neural Connectivity, Bother
Brief 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. 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: 1. Match a group of non-bothered tinnitus patients on age and hearing status to an existing cohort of bothered tinnitus patients. 2. 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. 3. 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).
Interventions
OTHERNo intervention
No treatment for tinnitus will occur in this study.
Sponsors
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Changes in Blood Oxygen Level as Measured by Functional Connectivity MRI | 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. |
Countries
United States
Participant flow
Recruitment details
Those with subjective, idiopathic tinnitus were recruited from WU audiology and otolaryngology clinics.
Pre-assignment details
1 participant was excluded due to claustrophobia from the MRI and another participant withdrew midway through the neurocognitive evaluation due to frustration.
Participants by arm
| Arm | Count |
|---|---|
| Non-Bothered Tinnitus Group Participants who answer no bother or slight bother on a global tinnitus bothersome score. Tinnitus Handicap Index \<30. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Claustrophibia and Frustration | 2 |
Baseline characteristics
| Characteristic | Non-Bothered Tinnitus Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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.
Time frame: 8 months for complete analysis on all participants
Population: Perform Functional Connectivity MRI on Participants With Non-bothersome Tinnitus. Non-Bothered Tinnitus Group includes participants who answer 'no bother' or 'slight bother' on a global tinnitus bothersome scale and less than 30 on the Tinnitus Handicap Index.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Bothered Tinnitus Group | Number of Participants With Changes in Blood Oxygen Level as Measured by Functional Connectivity MRI | 18 participants |
Comparison: Null hypothesis: Fisher's transform z scores for a seed region were comparable between the control and non-bothered tinnitus groups.p-value: <0.01Fisher Exact