Exploration of Cortical Neural Network in Patients With Bothersome Tinnitus

NCT ID: NCT01385540

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-08-31

Brief Summary

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.

Detailed Description

Task-Based Functional Magnetic Resonance Imaging (fMRI) The task-based fMRI protocol is based on work performed at Washington University by Dr. Gordon Shulman and published in The Journal of Neuroscience.(Shulman, Astafiev, Franke, Pope, Snyder, McAvoy, and Corbetta 2009) Individuals will be shown a target, which is randomly selected from 12 objects designated as targets, before each scan. The target for a scan will never appear as a non-target object in another scan. Per established protocol, individuals will fixate on a central cross prior to imaging. Individuals will press a MR-compatible button when they detect the target. Target objects only appear in the cued stream. Cues, a filled red square, are programmed to occur, on average, every 2.06, 4.12, or 6.18 seconds within a temporal window of ± 400 milliseconds centered on those values.

Conditions

Tinnitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Task-based fMRI

Task-Based Functional Magnetic Resonance Imaging (fMRI)

Intervention Type: BEHAVIORAL

Individuals will be shown a target, which is randomly selected from 12 objects designated as targets, before each scan. The target for a scan will never appear as a non-target object in another scan. Per established protocol, individuals will fixate on a central cross prior to imaging. Individuals will press a MR-compatible button when they detect the target. Target objects only appear in the cued stream. Cues, a filled red square, are programmed to occur, on average, every 2.06, 4.12, or 6.18 seconds within a temporal window of ± 400 milliseconds centered on those values.

Interventions

Task-Based Functional Magnetic Resonance Imaging (fMRI)

Individuals will be shown a target, which is randomly selected from 12 objects designated as targets, before each scan. The target for a scan will never appear as a non-target object in another scan. Per established protocol, individuals will fixate on a central cross prior to imaging. Individuals will press a MR-compatible button when they detect the target. Target objects only appear in the cued stream. Cues, a filled red square, are programmed to occur, on average, every 2.06, 4.12, or 6.18 seconds within a temporal window of ± 400 milliseconds centered on those values.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Tinnitus Association

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jay F. Piccirillo, MD

Professor, Washington University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay F Piccirillo, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201106289

Identifier Type: -

Identifier Source: org_study_id