Cognitive Training for Firefighters With Tinnitus

Tinnitus Clinical Trial

— FEMAICT  

Official title:

Investigating the Impact of Cognitive Training for Firefighters With Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458821
• Other study ID #: 201110046
• Secondary ID: EMW-2010-FP-0060
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2011
• Last updated: May 7, 2014
• Start date: March 2012
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Brain Fitness Program - 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Federal Emergency Management Agency

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use.	Patient-based rating scale of tinnitus severity	8 weeks.	No
Secondary	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	No