Task-Based Functional MRI (fMRI) in Patients With Severely Bothersome Tinnitus
|ClinicalTrials.gov Identifier: NCT01172262|
Recruitment Status : Withdrawn (Study did not recieve funding, currenlty undergoing protocol revision.)
First Posted : July 29, 2010
Last Update Posted : August 1, 2011
|Condition or disease||Intervention/treatment|
Tinnitus is the perceived sensation of sound without actual acoustic stimulation that affects 50 million Americans, with 15 million being significantly bothered. Using functional connectivity MRI (fcMRI), the investigators have found distinct differences in the cortical attention networks between patients with bothersome tinnitus and age-matched controls. These novel findings suggest that some of the classic and most disturbing characteristics of tinnitus result from derangements in cortical pathways. Using a validated task-based functional MRI (fMRI) paradigm developed at Washington University, the investigators will explore the ventral and dorsal frontoparietal cortical attention networks in patients with bothersome tinnitus and non-tinnitus controls.
This will be an experimental task-based fMRI pilot study involving the neurocognitive and neuroimaging assessment of patients with severely bothersome tinnitus.
The investigators plan to perform a pilot study and enroll a total of 10 subjects to undergo task-based imaging. These results will be compared to a control (no tinnitus) cohort (n=35) that has already undergone task-based fMRI. This task-based paradigm will allow us to advance knowledge about the role of the attention, control, and other cortical networks in the development and maintenance of bothersome tinnitus.
The investigators anticipate it will take one year to successfully enroll and test a total of 10 patients. All scans will be performed on the Washington University grounds.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Task-Based Functional MRI (fMRI) Exploration of the Cortical Attention Network in Patients With Severely Bothersome Tinnitus|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||February 2012|
Either responds with a Global Tinnitus Scale of Moderately or Severely Bothered. Score >30 on the Tinnitus Handicap Index (THI).
This is an observational study, no intervention will occur.
Other Name: This is an observational study, no intervention will occur.
- Perform task based functional imaging on severely bothered tinnitus patients [ Time Frame: Analysis will begin after a participant is finished with the study, we anticipate two weeks per patient for complete analysis. Multiple patients can be analyzed at concurrently. ]By undergoing a task based function MRI, we are able to delineate the various attention networks involved with tinnitus. By isolating these networks, insight will be gained on why bothered tinnitus patients have such difficutly.
- Perform neurocognitive testing on severely bother tinnitus patients [ Time Frame: Analysis will begin after a participant is finished with the study, we anticipate two weeks per patient for complete analysis. Multiple patients can be analyzed at concurrently. ]Through our previously experiences, we have found that those patients with severely bothersome tinnitus have difficulty with neurocognitive testing involving memory and attention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172262
|Principal Investigator:||Andre M Wineland, MD||Washington University School of Medicine|