Processing Speed as an Objective Measure of Tinnitus

Tinnitus Clinical Trial

— BST  

Official title:

Processing Speed as an Objective Measure of Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222507
• Other study ID #: 10-0829
• Status: Completed
• Phase: N/A
• First received: October 15, 2010
• Last updated: September 18, 2012
• Start date: July 2010
• Est. completion date: October 2010

Study information

• Verified date: September 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Tinnitus

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	Posit Science Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Initial study visit	No