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

July 29, 2011 updated by: Washington University School of Medicine

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University, Center for Clinical Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Slightly or Non-Bothered Tinnitus Group
Other: No intervention
No treatment for tinnitus will occur in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recruit 20 participants and have them undergo both neuro-cognitive and neuro-imaging testing.
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

August 1, 2011

Last Update Submitted That Met QC Criteria

July 29, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WU01201982

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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