Tinnitus Measured by MEG and Synchronous Neural Interaction™ Test: Template Development
Recruitment status was Recruiting
The study is designed to identify specific patterns of brain functional activity associated with chronic, moderate to severe tinnitus through the use of resting-state MEG scans. Robust patterns identified in this study will be used as a biomarker for subsequent clinical evaluation of experimental drug treatments for tinnitus. This study will conduct MEG scans on approximately 30 to 75 subjects with tinnitus and approximately 15 healthy control subjects. MEG scans will be obtained for each subject following screening, clinical and tinnitus evaluations. A subset of 6 subjects from the tinnitus cohort will be invited to undergo evoked auditory assessment during an extended MEG scan session to identify cortical regions that respond to the auditory stimulus. These six subjects also will be evaluated with a single structural MRI scan to support high-resolution mapping of the localized cortical regions. MEG data will be analyzed to identify patterns of brain activity that are specifically associated with the presence of tinnitus using both standard approaches and the Orasi Synchronous Neural Interaction™ (SNI) test. MEG scan results also will be evaluated to identify specific patterns of functional activity that correlate with other measures of tinnitus severity such as the Iowa Tinnitus Handicap Scale. This study will test the hypothesis that moderate to severe tinnitus is associated with altered patterns of brain functional activity measured by a brief, resting-state MEG scan. This hypothesis will be tested by comparing resting-state MEG scans of tinnitus patients with those the of healthy control subjects collected during this study and available in Orasi's existing MEG scan database.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Moderate to Severe Tinnitus as Measured by MEG and the Synchronous Neural Interaction™ Test: Template Development Study|
- Correlated brain activity [ Time Frame: 1 day ] [ Designated as safety issue: No ]MEG scan data will be analyzed using standard frequency domain approaches and the Orasi SNI test for correlated, synchronous activity.
- Tinnitus Severity Ratings [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]The degree of tinnitus severity also will be evaluated using the Iowa Tinnitus Handicap Questionnaire (THQ), Tinnitus Handicap Inventory (THI) and a Visual Analog Scale (VAS) of Tinnitus Severity.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Subjects with chronic, moderate to severe unilateral tinnitus.
|Healthy control subjects|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185990
|United States, Minnesota|
|Noran Neurological Clinic||Recruiting|
|Minneapolis, Minnesota, United States, 55407|
|Contact: Ann Rechtzigel, BSN 612-708-5357 firstname.lastname@example.org|
|Principal Investigator: Richard E Golden, MD|
|Minneapolis, Minnesota, United States, 55435|
|Contact: Anne-Marie Tschida 952-922-7000 ext 4640 email@example.com|
|Principal Investigator: Tami Helmer, MD|
|Principal Investigator:||Richard E Golden, MD||Noran Neurological Clinic|
|Principal Investigator:||Tami Helmer, MD||Radiant Research|