Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother
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|ClinicalTrials.gov Identifier: NCT01049828|
Recruitment Status : Unknown
Verified July 2011 by Washington University School of Medicine.
Recruitment status was: Active, not recruiting
First Posted : January 15, 2010
Last Update Posted : August 1, 2011
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:
- Match a group of non-bothered tinnitus patients on age and hearing status to an existing cohort of bothered tinnitus patients.
- 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.
- 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 or disease||Intervention/treatment|
|Tinnitus||Other: No intervention|
|Study Type :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
|Slightly or Non-Bothered Tinnitus Group||
Other: No intervention
No treatment for tinnitus will occur in this study.
- Recruit 20 participants and have them undergo both neuro-cognitive and neuro-imaging testing. [ Time Frame: 8 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049828
|United States, Missouri|
|Washington University, Center for Clinical Studies|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Andre M Wineland, MD||Washington University School of Medicine|