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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01049828
First received: January 14, 2010
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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).

Condition Intervention
Tinnitus
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Recruit 20 participants and have them undergo both neuro-cognitive and neuro-imaging testing. [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Slightly or Non-Bothered Tinnitus Group Other: No intervention
No treatment for tinnitus will occur in this study.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049828

Locations
United States, Missouri
Washington University, Center for Clinical Studies
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Andre M Wineland, MD Washington University Early Recognition Center
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andre M. Wineland, MD/ Principal Investigator, Washington University
ClinicalTrials.gov Identifier: NCT01049828     History of Changes
Other Study ID Numbers: WU01201982
Study First Received: January 14, 2010
Last Updated: July 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Tinnitus
fcMRI
Neural Connectivity
Bother

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014