TinnitusNCT01172262
Task-Based Functional MRI (fMRI) in Patients With Severely Bothersome Tinnitus
An observational study of Tinnitus, run by Washington University School of Medicine.
Trial summary
Tinnitus is a poorly understood symptom that is often described either as ringing, clicking, ocean sounds, or nature sounds. There is no cure for tinnitus. Approximately 50 million Americans are affected with a small minority being severely affected. This study targets patients with tinnitus who are severely bothered. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This is an observation study focusing on people who have tinnitus and are severely bothered. Recruit a total of 10 participants, preference given to those who live close to 63110.
Who may be able to join
- 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
- Able to give informed consent
- Able to read, write, speak and understand English fluently
- If applicable, a negative urine pregnancy test
- An audiogram within the past 12 months
- THI score >38
Who cannot join
- Patients experiencing tinnitus related to cochlear implantation, retrocochlear lesion, Ménière's Disease, or other known anatomic lesions of the ear and temporal bone
- Patients with hyperacusis or misophonia (hyper-sensitivity to noises)
- Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, or any other contraindication for MRI scan
- Patients with an acute or chronic unstable medical condition which, in the opinion of the investigator, would require stabilization prior to initiation of magnetic stimulation
- Patients with any active ear disease that, in the opinion of the PI, needs to be further evaluated
- Patients with symptoms of depression as evidenced by a score of 14 or greater on the Beck Depression Inventory
Show all 16Show fewer
- Any psychiatric co-morbidity that may complicate the interpretation of study results
- Any tinnitus related to a Workman's Compensation claim or litigation-related event
- Weight over 300 pounds
- A Mini-Mental Status Exam score less than 27
- Patients with a history of claustrophobia
- Inability to lay flat for 2 hour
- 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 informed consent
- Currently pregnant
About this study
Official title: Task-Based Functional MRI (fMRI) Exploration of the Cortical Attention Network in Patients With Severely Bothersome Tinnitus
Tinnitus is a poorly understood symptom that is often described either as ringing, clicking, ocean sounds, or nature sounds. There is no cure for tinnitus. Approximately 50 million Americans are affected with a small minority being severely affected. This study targets patients with tinnitus who are severely bothered. Through MRI the investigators plan to evaluate the cortical networks of the brain in hopes to better understand this complex process.
Read the detailed description
Tinnitus is the perceived sensation of sound without actual acoustic stimulation that affects 50 million Americans, with 15 million being significantly bothered. Using functional connectivity MRI (fcMRI), the investigators have found distinct differences in the cortical attention networks between patients with bothersome tinnitus and age-matched controls. These novel findings suggest that some of the classic and most disturbing characteristics of tinnitus result from derangements in cortical pathways. Using a validated task-based functional MRI (fMRI) paradigm developed at Washington University, the investigators will explore the ventral and dorsal frontoparietal cortical attention networks in patients with bothersome tinnitus and non-tinnitus controls.
This will be an experimental task-based fMRI pilot study involving the neurocognitive and neuroimaging assessment of patients with severely bothersome tinnitus.
The investigators plan to perform a pilot study and enroll a total of 10 subjects to undergo task-based imaging. These results will be compared to a control (no tinnitus) cohort (n=35) that has already undergone task-based fMRI. This task-based 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.
The investigators anticipate it will take one year to successfully enroll and test a total of 10 patients. All scans will be performed on the Washington University grounds.
- Conditions
- Tinnitus
- Being tested
- MRI
- Keywords
- Tinnitus, MRI, fMRI, task based MRI, Otolaryngology
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Also called This is an observational study, no intervention will occur.
This is an observational study, no intervention will occur.
| Study group | Role | What they receive |
|---|---|---|
| Bothered Tinnitus | Either responds with a Global Tinnitus Scale of Moderately or Severely Bothered. Score >30 on the Tinnitus Handicap Index (THI). Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perform task based functional imaging on severely bothered tinnitus patients
By undergoing a task based function MRI, we are able to delineate the various attention networks involved with tinnitus. By isolating these networks, insight will be gained on why bothered tinnitus patients have such difficutly.
Measured: Analysis will begin after a participant is finished with the study, we anticipate two weeks per patient for complete analysis. Multiple patients can be analyzed at concurrently.
Secondary outcomes (1)
Perform neurocognitive testing on severely bother tinnitus patients
Through our previously experiences, we have found that those patients with severely bothersome tinnitus have difficulty with neurocognitive testing involving memory and attention.
Measured: Analysis will begin after a participant is finished with the study, we anticipate two weeks per patient for complete analysis. Multiple patients can be analyzed at concurrently.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Why it stopped: Study did not recieve funding, currenlty undergoing protocol revision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre M Wineland, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172262
- Sponsor's protocol ID
- AMW04292010
- Other IDs
- Bothersome Tinnitus
- Status last verified
- Apr 2018
- First submitted
- 23 Jul 2010
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-Based Functional MRI (fMRI) Exploration of the Cortical Attention Network in Patients With Severely Bothersome Tinnitus
- ClinicalTrials.gov ID
- NCT01172262
- Acronym / sponsor ID
- AMW04292010
- Conditions
- Tinnitus
- Keywords
- Tinnitus, MRI, fMRI, task based MRI, Otolaryngology
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not recieve funding, currenlty undergoing protocol revision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tinnitus is a poorly understood symptom that is often described either as ringing, clicking, ocean sounds, or nature sounds. There is no cure for tinnitus. Approximately 50 million Americans are affected with a small minority being severely affected. This study targets patients with tinnitus who are severely bothered. Through MRI the investigators plan to evaluate the cortical networks of the brain in hopes to better understand this complex process.
Detailed description
Tinnitus is the perceived sensation of sound without actual acoustic stimulation that affects 50 million Americans, with 15 million being significantly bothered. Using functional connectivity MRI (fcMRI), the investigators have found distinct differences in the cortical attention networks between patients with bothersome tinnitus and age-matched controls. These novel findings suggest that some of the classic and most disturbing characteristics of tinnitus result from derangements in cortical pathways. Using a validated task-based functional MRI (fMRI) paradigm developed at Washington University, the investigators will explore the ventral and dorsal frontoparietal cortical attention networks in patients with bothersome tinnitus and non-tinnitus controls.
This will be an experimental task-based fMRI pilot study involving the neurocognitive and neuroimaging assessment of patients with severely bothersome tinnitus.
The investigators plan to perform a pilot study and enroll a total of 10 subjects to undergo task-based imaging. These results will be compared to a control (no tinnitus) cohort (n=35) that has already undergone task-based fMRI. This task-based 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.
The investigators anticipate it will take one year to successfully enroll and test a total of 10 patients. All scans will be performed on the Washington University grounds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bothered Tinnitus | – | Procedure: MRIEither responds with a Global Tinnitus Scale of Moderately or Severely Bothered. Score >30 on the Tinnitus Handicap Index (THI). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This is an observation study focusing on people who have tinnitus and are severely bothered. Recruit a total of 10 participants, preference given to those who live close to 63110.
Key inclusion criteria (8 listed)
- 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
- Able to give informed consent
- Able to read, write, speak and understand English fluently
Key exclusion criteria (16 listed)
- Patients experiencing tinnitus related to cochlear implantation, retrocochlear lesion, Ménière's Disease, or other known anatomic lesions of the ear and temporal bone
- Patients with hyperacusis or misophonia (hyper-sensitivity to noises)
- Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, or any other contraindication for MRI scan
- Patients with an acute or chronic unstable medical condition which, in the opinion of the investigator, would require stabilization prior to initiation of magnetic stimulation
- Patients with any active ear disease that, in the opinion of the PI, needs to be further evaluated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: This is an observational study, no intervention will occur.This is an observational study, no intervention will occur. | Procedure or surgery | Bothered Tinnitus |
Primary outcome
Perform task based functional imaging on severely bothered tinnitus patients
Time frame: Analysis will begin after a participant is finished with the study, we anticipate two weeks per patient for complete analysis. Multiple patients can be analyzed at concurrently.
By undergoing a task based function MRI, we are able to delineate the various attention networks involved with tinnitus. By isolating these networks, insight will be gained on why bothered tinnitus patients have such difficutly.
1 secondary outcome
Perform neurocognitive testing on severely bother tinnitus patients
Time frame: Analysis will begin after a participant is finished with the study, we anticipate two weeks per patient for complete analysis. Multiple patients can be analyzed at concurrently.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre M Wineland, MD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perform task based functional imaging on severely bothered tinnitus patients (time frame: Analysis will begin after a participant is finished with the study, we anticipate two weeks per patient for complete analysis. Multiple patients can be analyzed at concurrently.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.