Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT01458821
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.
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Notify Me20 year–65 year
All sexes
Interventional
Phase 3
St Louis, Missouri, 63110, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive.
Other names: Posit Science
Time frame: 8 weeks.
Patient-based rating scale of tinnitus severity
Time frame: 8 weeks
Neuropsychological test to assess an individual's verbal learning and memory abilities
Washington University School of Medicine
Other
Investigating the Impact of Cognitive Training for Firefighters With Tinnitus
Acronym: FEMAICT
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