NCT00973648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

September 8, 2009

Last Update Submit

June 10, 2013

Conditions

Tinnitus

Keywords

TinnitusRinging in earsFunctional connectivity MRIVoluntary control of tinnitus

Outcome Measures

Primary Outcomes (1)

  • Changes in brain neural activity between before and after tinnitus modulation as detected on functional connectivity MRI.

    After completion of functional connectivity MRI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Speciality clinic Community health centers Solicitation of participants from American Tinnitus Association and Acoustic Neuroma Society Research database

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Lee MH, Solowski N, Wineland A, Okuyemi O, Nicklaus J, Kallogjeri D, Piccirillo JF, Burton H. Functional connectivity during modulation of tinnitus with orofacial maneuvers. Otolaryngol Head Neck Surg. 2012 Oct;147(4):757-62. doi: 10.1177/0194599812450680. Epub 2012 Jun 6.

    PMID: 22675003RESULT

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jay F Piccirillo, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Otolaryngology, Director of Clinical Outcomes Research Office

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

February 1, 2012

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

US(1)