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NCT01049828 · ClinicalTrials.gov registry record
Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother
A clinical trial, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- 20
- Enrollment target
NCT01049828: Completed study, sponsored by Washington University School of Medicine.
NCT01049828 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01049828 has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study 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. 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,
Primary Outcome
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.
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-08 |
What the finished NCT01049828 record still lists
NCT01049828 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT01049828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01049828 about?
NCT01049828 is a clinical study titled "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 thei...
What is the current status of trial NCT01049828?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2010-08. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01049828?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT01049828?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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