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Cognitive Training for Firefighters With Tinnitus (FEMAICT)

This study has been completed.
Sponsor:
Collaborator:
Federal Emergency Management Agency
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University
ClinicalTrials.gov Identifier:
NCT01458821
First received: October 10, 2011
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Tinnitus
Behavioral: Brain Fitness Program - Tinnitus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigating the Impact of Cognitive Training for Firefighters With Tinnitus

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use. [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]
    Patient-based rating scale of tinnitus severity


Secondary Outcome Measures:
  • Change in Baseline Tinnitus Bother Score at 8 weeks post Brain Fitness Program Use. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Neuropsychological test to assess an individual's verbal learning and memory abilities


Enrollment: 60
Study Start Date: March 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Posit Science
No Intervention: No treatment
Subject will make no changes in their usual daily routine. No intervention. Will repeat all study procedures at end of 8 weeks.

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 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).

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458821

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Federal Emergency Management Agency
Investigators
Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Jay F. Piccirillo, MD, Professor, Washington University
ClinicalTrials.gov Identifier: NCT01458821     History of Changes
Other Study ID Numbers: 201110046, EMW-2010-FP-00601
Study First Received: October 10, 2011
Last Updated: May 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Tinnitus

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014