Cognitive Training for Firefighters With Tinnitus
FEMAICT
Investigating the Impact of Cognitive Training for Firefighters With Tinnitus
2 other identifiers
interventional
60
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2011
CompletedFirst Posted
Study publicly available on registry
October 25, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMay 9, 2014
May 1, 2014
1.8 years
October 10, 2011
May 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use.
Patient-based rating scale of tinnitus severity
8 weeks.
Secondary Outcomes (1)
Change in Baseline Tinnitus Bother Score at 8 weeks post Brain Fitness Program Use.
8 weeks
Study Arms (2)
Brain Fitness Program - Tinnitus
EXPERIMENTALBrain 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 INTERVENTIONSubject will make no changes in their usual daily routine. No intervention. Will repeat all study procedures at end of 8 weeks.
Interventions
Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive.
Eligibility Criteria
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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
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.
PMID: 28114646DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay F Piccirillo, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 10, 2011
First Posted
October 25, 2011
Study Start
March 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
May 9, 2014
Record last verified: 2014-05