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Cognitive Training for Firefighters With Tinnitus (FEMAICT)

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brain Fitness Program - Tinnitus
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brain Fitness Program - Tinnitus

No treatment

Arm Description

Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive.

Subject will make no changes in their usual daily routine. No intervention. Will repeat all study procedures at end of 8 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use.
Patient-based rating scale of tinnitus severity

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2011
Last Updated
May 7, 2014
Sponsor
Washington University School of Medicine
Collaborators
Federal Emergency Management Agency
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1. Study Identification

Unique Protocol Identification Number
NCT01458821
Brief Title
Cognitive Training for Firefighters With Tinnitus
Acronym
FEMAICT
Official Title
Investigating the Impact of Cognitive Training for Firefighters With Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Federal Emergency Management Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain Fitness Program - Tinnitus
Arm Type
Experimental
Arm Description
Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Subject will make no changes in their usual daily routine. No intervention. Will repeat all study procedures at end of 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Brain Fitness Program - Tinnitus
Other Intervention Name(s)
Posit Science
Intervention Description
Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive.
Primary Outcome Measure Information:
Title
Change from Baseline in Tinnitus Handicap Inventory at 8 weeks post Brain Fitness use.
Description
Patient-based rating scale of tinnitus severity
Time Frame
8 weeks.
Secondary Outcome Measure Information:
Title
Change in Baseline Tinnitus Bother Score at 8 weeks post Brain Fitness Program Use.
Description
Neuropsychological test to assess an individual's verbal learning and memory abilities
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay F Piccirillo, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28114646
Citation
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.
Results Reference
derived

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Cognitive Training for Firefighters With Tinnitus

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