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Exploring Voluntary Control of Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973648
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : June 11, 2013
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine

Brief Summary:
This pilot study aims to increase the understanding of tinnitus through the identification of potentially altered brain networks in patients who are able to voluntarily control or alter their tinnitus. Upon completion of this study, new knowledge will be gained about the changes in brain activity in people who are able to modify their tinnitus.

Condition or disease

Detailed Description:

Certain patients report that they are able to modulate the loudness or pitch of their tinnitus temporarily through various means, including attention re-direction or somatosensory mechanisms such as oral facial movements or head turn. This subset of patients may represent a unique opportunity for the researcher to gain insight into the mechanisms responsible for tinnitus.

Neural activity in the brain has been linked to increases in blood flow and blood oxygenation. These changes in the concentration of oxyhemoglobin versus deoxyhemoglobin alter the magnetic resonance signal of blood which may then be detected using an appropriate MR pulse sequence as blood-oxygen-level-dependent (BOLD) contrast. In addition to increases in blood flow due to evoked neural activity, the brain exhibits continuous low frequency spontaneous activity. These fluctuations tend to be synchronous in functionally related, but spatially distinct, regions of the brain even when not performing a prescribed task. The phrase functional connectivity has been used to implicate the neural activity that facilitates the coordinated activity of functionally related brain regions.

This study will use functional connectivity magnetic resonance imaging (fcMRI) to measure the network of synchronous brain activity in patients with tinnitus. Several targeted networks are those linked to the auditory system, attention, and control systems and the emotion systems linked to prefrontal cortex. Previously, functional MRI (fMRI) used changes in blood flow and blood oxygenation within the brain to detect which isolated regions of the brain were active during a task. The goal of functional connectivity research is to describe a pattern of interactions or a picture of the connectivity that occurs within distinct regions of the brain when the individual is not involved in a task.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exploring Voluntary Control of Tinnitus: A Pilot Study
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Primary Outcome Measures :
  1. Changes in brain neural activity between before and after tinnitus modulation as detected on functional connectivity MRI. [ Time Frame: After completion of functional connectivity MRI ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Speciality clinic Community health centers Solicitation of participants from American Tinnitus Association and Acoustic Neuroma Society Research database

Inclusion Criteria:

  • Adults, between the ages of 18 and 80 years.
  • Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater.
  • Patient has some voluntary control over their tinnitus, whether through attention redirection or somatosensory control, such as orofacial movements or head turn.
  • Able to give informed consent.
  • English-speaking.

Exclusion Criteria:

  • Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone.
  • Patients with hyperacusis or misophonia (hyper-sensitivity to loud noises).
  • Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, or other intracranial metal objects with the exception of dental fillings or any other contraindication for MRI scan.
  • Patients with an acute or unstable medical condition including all individuals with any significant heart disease, history of seizures, pneumonia, recent hip fracture (within 3 months), acute GI bleed, uncontrolled hypertension, or other disorders which would require stabilization prior to initiation of imaging.
  • Patients with a history of a brain-related injury or brain-related illness such as increased intracranial pressure, brain mass, Huntington's chorea).
  • Patients currently taking psychoactive drugs that cannot be suspended for several days prior to imaging.
  • Weight over 350 pounds.
  • Patients with a history of claustrophobia.
  • Patients who have an inability to lay flat for 1 hour.
  • Patients with tinnitus related to Workman's Compensation claim or litigation-related event.
  • Patients whose ability to give informed consent is in question.
  • Any exclusions from radiology screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973648

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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine
Publications of Results:
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Responsible Party: Jay F. Piccirillo, MD, Professor of Otolaryngology, Director of Clinical Outcomes Research Office, Washington University School of Medicine Identifier: NCT00973648    
Other Study ID Numbers: 09-0481
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013
Keywords provided by Jay F. Piccirillo, MD, Washington University School of Medicine:
Ringing in ears
Functional connectivity MRI
Voluntary control of tinnitus
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases