- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385540
Exploration of Cortical Neural Network in Patients With Bothersome Tinnitus
February 29, 2012 updated by: Jay F. Piccirillo, MD, Washington University School of Medicine
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
7
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
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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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 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Task-based 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
July 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
June 28, 2011
First Submitted That Met QC Criteria
June 29, 2011
First Posted (Estimate)
June 30, 2011
Study Record Updates
Last Update Posted (Estimate)
March 2, 2012
Last Update Submitted That Met QC Criteria
February 29, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201106289
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
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State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
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Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
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University of ZurichCompletedTinnitus, SubjectiveGermany, Switzerland
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