Processing Speed as an Objective Measure of Tinnitus

Completed

• Conditions: Tinnitus

• Registration Number: NCT01222507
• Lead Sponsor: Washington University School of Medicine

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".

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Status Verified: 2012-09
• Results First Submitted: 2012-09-18
• Results First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Results First Posted: 2012-10-25
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States