Status:
WITHDRAWN
Task-Based Functional MRI (fMRI) in Patients With Severely Bothersome Tinnitus
Lead Sponsor:
Washington University School of Medicine
Conditions:
Tinnitus
Eligibility:
All Genders
18-60 years
Brief Summary
Tinnitus is a poorly understood symptom that is often described either as ringing, clicking, ocean sounds, or nature sounds. There is no cure for tinnitus. Approximately 50 million Americans are affec...
Detailed Description
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 (fcM...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18 to 60 years
- Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater
- Either "moderately bothered" or "severely bothered" on the Global Bothersome scale
- Able to give informed consent
- Able to read, write, speak and understand English fluently
- If applicable, a negative urine pregnancy test
- An audiogram within the past 12 months
- THI score \>38
Exclusion
- Patients experiencing tinnitus related to cochlear implantation, retrocochlear lesion, Ménière's Disease, or other known anatomic lesions of the ear and temporal bone
- Patients with hyperacusis or misophonia (hyper-sensitivity to noises)
- Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, 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
- Any psychiatric co-morbidity that may complicate the interpretation of study results
- Any tinnitus related to a Workman's Compensation claim or litigation-related event
- Weight over 300 pounds
- A Mini-Mental Status Exam score less than 27
- Patients with a history of claustrophobia
- Inability to lay flat for 2 hour
- 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
- Currently pregnant
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01172262
Start Date
February 1 2011
End Date
February 1 2012
Last Update
May 3 2018
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