Exploration of Cortical Neural Network in Patients With Bothersome Tinnitus

NCT01385540 | Terminated

• 1 other identifier: 201106289
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Tinnitus, fMRI, task-based fMRI, attention network

Study Arms (1)

Task-based fMRI

Behavioral: Task-Based Functional Magnetic Resonance Imaging (fMRI)

Interventions

Task-Based Functional Magnetic Resonance Imaging (fMRI) 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.

Task-based fMRI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Target population will consist of 12 adult participants - 6 with moderately, severely or worse, bothersome tinnitus, based on both a global bothersome score (i.e. How bothered are you by your tinnitus?) and the Tinnitus Handicap Index (THI). THI is a 25-question survey designed to assess how much tinnitus affects a person-possible scores range from 0-100, with a score 38 falling in the 75th percentile. The other six participants (Control group) will be age-matched without tinnitus.

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American Tinnitus Association: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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

• Jay F Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Washington University School of Medicine

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 30, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 2, 2012

Record last verified: 2012-02

Locations

US (1)