Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother

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).

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University, Center for Clinical Studies

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No treatment for tinnitus will occur in this study.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jan 15, 2010
Registry last updated: Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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