Exploration of Cortical Neural Network in Patients With Bothersome Tinnitus

This study has been terminated.
(Study tasks to difficult for subjects to complete.)
Sponsor:
Collaborator:
American Tinnitus Association
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01385540
First received: June 28, 2011
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Exploration of Cortical Neural Network in Patients With Bothersome Tinnitus

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Enrollment: 7
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Task-based fMRI Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385540

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
American Tinnitus Association
Investigators
Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Jay F. Piccirillo, MD, Professor, Washington University School of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01385540     History of Changes
Other Study ID Numbers: 201106289
Study First Received: June 28, 2011
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Tinnitus, fMRI, task-based fMRI, attention network

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014