TinnitusPhase 3FEMAICTNCT01458821
Cognitive Training for Firefighters With Tinnitus
A Phase 3 study testing Brain Fitness Program - Tinnitus in people with Tinnitus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether the Brain Fitness Program-Tinnitus affects how tinnitus is perceived and if its use aids in the recovery of cognitive functions that may be affected by tinnitus. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Brain Fitness Program - Tinnitus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jan 2014
- Phase
- Phase 3
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- Men and women between the ages of 20 and 65 years
- Must be able to read, write, and understand English
- Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater
- Score of 3, 4, or 5 on the Global Bothersome scale
- Have access to uninterrupted use of computer in quiet setting for minimum of 1 hour per day/5 days per week for 2 months.
- Be willing to be randomized to either arm of the study.
Who cannot join
- Currently taking medication for depression, anxiety, or other DSM IV Axis 1 disorder
- History of head trauma sufficient to cause loss of consciousness for ≥30 minutes
- History of surgery to the brain
- History of claustrophobia, which will prevent subject from completing MRI
- Presence of metallic implants in the head and upper cervical region that are non-MRI compatible and would prohibit use of MRI
- Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, or any other contraindication for MRI scan
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- Currently pregnant
- Patients with an acute or chronic unstable medical condition, which, in the opinion of the investigator, would prevent them from successfully participating in the study
- Patients with any active ear disease, which, in the opinion of the PI, needs to be further evaluated
- Patients with symptoms of depression as evidenced by a score of 15 or greater on the PHQ-9
- Any psychiatric co-morbidity that may complicate the interpretation of study results
- History of seizure disorder or any other neurological condition
- Weight over 350 pounds
- 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, which, in the opinion of the PI, confounds study results or places the subject at greater risk
- Prior use of Posit Science Brain Fitness Program, or any other cognitive training program (regular or tinnitus) in the past year
- Patients with hyperacusis (hyper-sensitivity to noises) or misophonia (abnormally strong reactions of the autonomic and limbic systems to sound)
- Tinnitus related to cochlear implantation, retrocochlear lesion, Meniere's Disease, or other known anatomic lesions of the ear or temporal bone
- Tinnitus related to a Workman's Compensation claim or litigation-related event that is still pending.
- History of irritable bowel syndrome, fibromyalgia, chronic fatigue syndrome, or other illnesses or disorders that falls into the category of functional somatic syndromes.(Barsky and Borus 1999)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Investigating the Impact of Cognitive Training for Firefighters With Tinnitus
The purpose of this research study is to determine whether the Brain Fitness Program-Tinnitus affects how tinnitus is perceived and if its use aids in the recovery of cognitive functions that may be affected by tinnitus. The investigators hope to better understand areas of the brain involved with or changed because of tinnitus. The investigators also hope to see if the Brain Fitness Program-Tinnitus impacts changes in those areas of the brain the investigators believe may be affected by tinnitus.
Read the detailed description
The objective of this pilot research project is to advance knowledge about the role of attention, control, and other cortical networks in the development and maintenance of bothersome tinnitus.
The investigators have three specific aims. First, determine whether the Brain Fitness Program-Tinnitus affects the tinnitus percept and aids the recovery of cognitive functions apparently "highjacked" by the tinnitus. Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive. Second, establish specific default mode, attention system, and cognitive control network deficits in patients with bothersome tinnitus through the use of advanced neuroimaging techniques. Third, assess whether exposure to the Brain Fitness Program-Tinnitus impacts changes in the default mode, attention system, and cognitive control network deficits.
The investigators will employ a randomized clinical trial design among a cohort of active-duty firefighters who experience bothersome tinnitus. A planned enrollment of 40 firefighters with tinnitus in the clinical trial will have sufficient statistical power to detect a 17-point change in Tinnitus Handicap Inventory scores. In addition, a previously developed fcMRI protocol will be used to study brain activity in regions associated with voluntary, involuntary, and executive control of attention in 60 firefighters (40 firefighters enrolled in the clinical trial and 20 firefighters without tinnitus).
- Conditions
- Tinnitus
- Being tested
- Brain Fitness Program - Tinnitus
- Keywords
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Fitness Program - TinnitusBehavioural
Also called Posit Science
Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive.
| Study group | Role | What they receive |
|---|---|---|
| Brain Fitness Program - Tinnitus | Experimental | Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive. Receives: Behavioral: Brain Fitness Program - Tinnitus |
| No treatment | No intervention | Subject will make no changes in their usual daily routine. No intervention. Will repeat all study procedures at end of 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use.
Patient-based rating scale of tinnitus severity
Measured: 8 weeks.
Secondary outcomes (1)
Change in Baseline Tinnitus Bother Score at 8 weeks post Brain Fitness Program Use.
Neuropsychological test to assess an individual's verbal learning and memory abilities
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Responsible party
- Principal investigator, Jay F. Piccirillo, MD, Washington University School of Medicine
- Investigators
- Jay F Piccirillo, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458821
- Sponsor's protocol ID
- 201110046
- Other IDs
- EMW-2010-FP-00601
- Acronym
- FEMAICT
- Status last verified
- May 2014
- First submitted
- 10 Oct 2011
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kallogjeri D, Piccirillo JF, Spitznagel E Jr, Hale S, Nicklaus JE, Hardin FM, Shimony JS, Coalson RS, Schlaggar BL. Cognitive Training for Adults With Bothersome Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 May 1;143(5):443-451. doi: 10.1001/jamaoto.2016.3779.
PubMed 28114646
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Cognitive Training for Firefighters With Tinnitus
- ClinicalTrials.gov ID
- NCT01458821
- Acronym / sponsor ID
- FEMAICT / 201110046
- Conditions
- Tinnitus
- Keywords
- Tinnitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Oct 2011 (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.
The purpose of this research study is to determine whether the Brain Fitness Program-Tinnitus affects how tinnitus is perceived and if its use aids in the recovery of cognitive functions that may be affected by tinnitus. The investigators hope to better understand areas of the brain involved with or changed because of tinnitus. The investigators also hope to see if the Brain Fitness Program-Tinnitus impacts changes in those areas of the brain the investigators believe may be affected by tinnitus.
Detailed description
The objective of this pilot research project is to advance knowledge about the role of attention, control, and other cortical networks in the development and maintenance of bothersome tinnitus.
The investigators have three specific aims. First, determine whether the Brain Fitness Program-Tinnitus affects the tinnitus percept and aids the recovery of cognitive functions apparently "highjacked" by the tinnitus. Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive. Second, establish specific default mode, attention system, and cognitive control network deficits in patients with bothersome tinnitus through the use of advanced neuroimaging techniques. Third, assess whether exposure to the Brain Fitness Program-Tinnitus impacts changes in the default mode, attention system, and cognitive control network deficits.
The investigators will employ a randomized clinical trial design among a cohort of active-duty firefighters who experience bothersome tinnitus. A planned enrollment of 40 firefighters with tinnitus in the clinical trial will have sufficient statistical power to detect a 17-point change in Tinnitus Handicap Inventory scores. In addition, a previously developed fcMRI protocol will be used to study brain activity in regions associated with voluntary, involuntary, and executive control of attention in 60 firefighters (40 firefighters enrolled in the clinical trial and 20 firefighters without tinnitus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Fitness Program - Tinnitus | Experimental | Behavioral: Brain Fitness Program - TinnitusBrain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive. |
| No treatment | No intervention | –Subject will make no changes in their usual daily routine. No intervention. Will repeat all study procedures at end of 8 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to give informed consent
- Men and women between the ages of 20 and 65 years
- Must be able to read, write, and understand English
- Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater
- Score of 3, 4, or 5 on the Global Bothersome scale
Key exclusion criteria (21 listed)
- Currently taking medication for depression, anxiety, or other DSM IV Axis 1 disorder
- History of head trauma sufficient to cause loss of consciousness for ≥30 minutes
- History of surgery to the brain
- History of claustrophobia, which will prevent subject from completing MRI
- Presence of metallic implants in the head and upper cervical region that are non-MRI compatible and would prohibit use of MRI
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 |
|---|---|---|
| Brain Fitness Program - TinnitusAlso: Posit ScienceBrain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive. | Behavioural | Brain Fitness Program - Tinnitus |
Primary outcome
Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use.
Time frame: 8 weeks.
Patient-based rating scale of tinnitus severity
1 secondary outcome
Change in Baseline Tinnitus Bother Score at 8 weeks post Brain Fitness Program Use.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Derived from this study: PubMed 28114646Kallogjeri D, Piccirillo JF, Spitznagel E Jr, Hale S, Nicklaus JE, Hardin FM, Shimony JS, Coalson RS, Schlaggar BL. Cognitive Training for Adults With Bothersome Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 May 1;143(5):443-451. doi: 10.1001/jamaoto.2016.3779.
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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.
Jay F Piccirillo, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brain Fitness Program - Tinnitus in people with Tinnitus, run by Washington University School of Medicine at 1 site in United States.
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 7 inclusion and 21 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: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use. (time frame: 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01458821, which also lists 1 linked publication.
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 9 May 2014.