Processing Speed as an Objective Measure of Tinnitus

NCT01222507 | Completed Results

• 1 other identifier: 10-0829
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

tinnitus; cognition; brain processing speed; Brain Fitness Program; Posit Science

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Brain Speed Test

60 subjects who complete 60 Second Brain Game and Brain Speed Test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tinnitus subjects recruited from speciality clinic and community at large.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Posit Science Corporation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jay Piccirillo
• Organization: Washington University

piccirilloj@ent.wustl.edu

314-362-7508

Study Officials

• Jay Piccirillo, MD

  Washington Unieversity

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Washington University School of Medicine

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 25, 2012
• Results First Posted: October 25, 2012

Record last verified: 2012-09

Locations

US (1)