Status:
COMPLETED
Cognitive Training for Firefighters With Tinnitus
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Federal Emergency Management Agency
Conditions:
Tinnitus
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief 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 a...
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01458821
Start Date
March 1 2012
End Date
January 1 2014
Last Update
May 9 2014
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110