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| ID | Type | Description | Link |
|---|---|---|---|
| EMW-2010-FP-00601 | Other Grant/Funding Number | FEMA Assistance to Firefighters Grant Program |
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| Name | Class |
|---|---|
| Federal Emergency Management Agency | FED |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Fitness Program - Tinnitus | Behavioral | Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use. | Patient-based rating scale of tinnitus severity | 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay F Piccirillo, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28114646 | Derived | 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. |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |