Task-Based Functional MRI (fMRI) in Patients With Severely Bothersome Tinnitus

NCT01172262 | Withdrawn

• 2 other identifiers: AMW04292010Bothersome Tinnitus
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 affected with a small minority being severely affected. This study targets patients with tinnitus who are severely bothered. Through MRI the investigators plan to evaluate the cortical networks of the brain in hopes to better understand this complex process.

Conditions

Tinnitus

Keywords

Tinnitus; MRI; fMRI; task based MRI; Otolaryngology

Outcome Measures

Primary Outcomes (1)

• Perform task based functional imaging on severely bothered tinnitus patients

  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.

  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.

Secondary Outcomes (1)

• Perform neurocognitive testing on severely bother tinnitus patients

  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.

Study Arms (1)

Bothered Tinnitus

Either responds with a Global Tinnitus Scale of Moderately or Severely Bothered. Score \>30 on the Tinnitus Handicap Index (THI).

Procedure: MRI

Interventions

MRI PROCEDURE

This is an observational study, no intervention will occur.

Also known as: This is an observational study, no intervention will occur.

Bothered Tinnitus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is an observation study focusing on people who have tinnitus and are severely bothered. Recruit a total of 10 participants, preference given to those who live close to 63110.

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andre M Wineland, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 29, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 3, 2018

Record last verified: 2018-04