Exploration of Cortical Neural Network in Patients With Bothersome Tinnitus

Stopped early

Conditions studied: Tinnitus

In brief

This will be an experimental task-based functional MRI pilot study involving the neuroimaging assessment of patients with severely bothersome tinnitus, defined by a global bothersome scale. The investigators plan to enroll a total of 12 participants (6 severely bothered tinnitus and 6 age-matched non-tinnitus controls) over the course of six months to undergo task-based imaging. Subjects in the tinnitus group may have previously participated in the CTRWU study (HRPO: 07-0689) conducted by Dr. Jay Piccirillo at Washington University and have given permission to be contacted for consideration in future studies. The selected 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.

Key facts

Study ID

NCT01385540

Run by

Washington University School of Medicine

People needed

7

Starts

2011-07-01

Expected to finish

2011-08-01

Last updated by the study team

2012-03-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• THI score of ≥ 30.
• Able to give written informed consent
• Able to read, write, speak and understand English fluently

You may not qualify if…

• Tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic lesions of the ear and temporal bone
• History of Ménière's Disease
• History of hyperacusis or misophonia (hyper-sensitivity to noises)
• Cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, or any other contraindication for MRI scan
• An acute or chronic unstable medical condition which, in the opinion of the investigator, would require stabilization prior to testing.
• Any active ear disease that, in the opinion of the PI or mentor, needs to be further evaluated
• A Short Blessed Test score of 9 or greater
• PHQ-9 score ≥ 10; consistent with diagnosis of moderate depression.
• History of seizure disorder or other neurological condition.
• Any psychiatric co-morbidity that may complicate the interpretation of study results. Subjects may not be currently taking antidepressants.
• Any tinnitus related to a Workman's Compensation claim or litigation-related event
• Currently pregnant: Women of childbearing potential must have a negative urine pregnancy test prior to MRI
• Weight over 300 pounds
• 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 written informed consent
• Blindness or inability to see screen for task-based testing without eyeglasses, subjects may wear contacts if able to lie flat and keep eyes focused on testing screen for up to 2 hours.
• Previous participation in a task-based MRI study

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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