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

NCT01049828 | Completed Results

• 1 other identifier: WU625296
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Match a group of non-bothered tinnitus patients on age and hearing status to an existing cohort of bothered tinnitus patients.
2. 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. 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).

Conditions

Tinnitus

Keywords

Tinnitus; fcMRI; Neural Connectivity; Bother

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months for complete analysis on all participants

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

No treatment for tinnitus will occur in this study.

Slightly or Non-Bothered Tinnitus Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University, Center for Clinical Studies

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 22722065 RESULT

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Andre Wineland
• Organization: Washington University in St. Louis

winelanda@ent.wustl.edu

314-362-5296

Study Officials

• Andre M Wineland, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 15, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-02

Locations

US (1)