Tinnitus
Conditions
Keywords
tinnitus, cognition, brain processing speed, Brain Fitness Program, Posit Science
Brief summary
The overall purpose of this research is to assess whether both the 60 second Brain Game and the Brain Speed Test computer-based programs can be used as assessment tools for objectively defining the severity of the functional impact of tinnitus.
Detailed description
This cross-sectional study aims to assess for deficits in brain processing speed and attention (two cognitive domains whose deficits have been implicated in tinnitus) with the use of the Brain Speed Test.
Interventions
None listed
Sponsors
Posit Science Corporation
Washington University School of Medicine
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants must be between the ages of 18 and 80. * Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6-months duration or longer. * Participants must be able to read, write and speak using the English language. * Participants must be able to provide informed consent.
Exclusion criteria
* Participants with tinnitus related to Workman's Compensation Claim or other litigation-related situations. * Participants with active diagnoses of any acute or chronic brain-related neurological conditions that alter normal brain anatomy or function including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, traumatic brain injury, history of brain tumor(s), epilepsy, or dementia. * Participants with tinnitus related to retrocochlear lesions, cochlear implants, or other known anatomic/structural lesions of the brain, skull-base, temporal bone or ear. * Participants unable to hear the highest volume of the computer-based objective assessments. * Any medications that may affect or alter cognition including but not limited to sedatives, hypnotics, narcotics, or opiates. * Any medical condition the PI determines would compromise the safety of the participant or complicate the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Speed Test | Initial study visit | This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from Washington University ENT and Audiology Clinics, as well as from Washington Univerity Volunteers for Health recruitment enhancement core.
Pre-assignment details
2 subjects failed to meet inclusion/exclusion criteria after signing consent form.
Participants by arm
| Arm | Count |
|---|---|
| Brain Speed Test 60 subjects who complete 60 Second Brain Game and Brain Speed Test | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Brain Speed Test |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Brain Speed Test
This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.
Time frame: Initial study visit
Population: The number of subjects who completed the study according to protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brain Processing Speed | Brain Speed Test | -0.28 units on a scale |