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Processing Speed as an Objective Measure of Tinnitus (BST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01222507
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : October 25, 2012
Last Update Posted : October 25, 2012
Sponsor:
Collaborator:
Posit Science Corporation
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, 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.

Condition or disease
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".

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Study Type : Observational
Actual Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Processing Speed as an Objective Measure of Tinnitus
Study Start Date : July 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Group/Cohort
Brain Speed Test
60 subjects who complete 60 Second Brain Game and Brain Speed Test



Primary Outcome Measures :
  1. Brain Speed Test [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tinnitus subjects recruited from speciality clinic and community at large.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222507


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Posit Science Corporation
Investigators
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Principal Investigator: Jay Piccirillo, MD Washington Unieversity
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Responsible Party: Jay F. Piccirillo, MD, Professor, Washington University School of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01222507    
Other Study ID Numbers: 10-0829
First Posted: October 18, 2010    Key Record Dates
Results First Posted: October 25, 2012
Last Update Posted: October 25, 2012
Last Verified: September 2012
Keywords provided by Jay F. Piccirillo, MD, Washington University School of Medicine:
tinnitus
cognition
brain processing speed
Brain Fitness Program
Posit Science
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms