Exploring Voluntary Control of Tinnitus

June 10, 2013 updated by: Jay F. Piccirillo, MD, Washington University School of Medicine

Exploring Voluntary Control of Tinnitus: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After completion of functional connectivity MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe