Cognitive Training for Firefighters With Tinnitus

Completed · Phase 3

Conditions studied: Tinnitus

In brief

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.

Key facts

Study ID

NCT01458821

Run by

Washington University School of Medicine

People needed

60

Starts

2012-03-01

Expected to finish

2014-01-01

Last updated by the study team

2014-05-09

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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)

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.