Tinnitus Measured by MEG and Synchronous Neural Interaction™ Test: Template Development
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|ClinicalTrials.gov Identifier: NCT01185990|
Recruitment Status : Unknown
Verified March 2011 by Orasi Medical, Inc..
Recruitment status was: Recruiting
First Posted : August 20, 2010
Last Update Posted : March 23, 2011
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|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|Official Title:||Moderate to Severe Tinnitus as Measured by MEG and the Synchronous Neural Interaction™ Test: Template Development Study|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
Subjects with chronic, moderate to severe unilateral tinnitus.
|Healthy control subjects|
- Correlated brain activity [ Time Frame: 1 day ]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 ]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.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- Subject is between 18 and 75 years of age at the time of screening.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject is a non-smoker.
- Subject is judged to be in good health based on medical history and brief physical examination.
- Subject has a diagnosis of chronic, moderate to severe (Tinnitus Handicap Inventory score range of 38 - 76, inclusive), unilateral tinnitus of unknown etiology, or is participating in the study as a healthy control subject.
- Subject has severe hearing impairment, external or middle ear diseases or temporomandibular joint disorders.
- Subject has a diagnosis of a significant neurological condition including Alzheimer's disease, Parkinson's disease, vascular dementia, Lewy body dementia or frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, or severe traumatic brain injury.
- Subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder.
- Subject has a history of seizures, epilepsy, stroke, peripheral neuropathy, head trauma with persistent post-concussive symptoms, ADHD, dyslexia or other clinically significant neurological disease or cognitive impairment.
- Subject has a current episode of major depressive disorder.
- Subject has used antidepressants, anxiolytics, antipsychotics or antiepileptic medications in the past 6 months.
- Subject has a recent (within 2 years) history of alcohol or substance abuse/dependence.
- Subject has completed an MRI within 2 weeks prior to the MEG scan.
- Subject has metal braces or pacemaker that may interfere with the MEG scan.
- Subject is unable to complete the MEG scan procedure.
- The investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation
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): NCT01185990
|United States, Minnesota|
|Noran Neurological Clinic||Recruiting|
|Minneapolis, Minnesota, United States, 55407|
|Contact: Ann Rechtzigel, BSN 612-708-5357 email@example.com|
|Principal Investigator: Richard E Golden, MD|
|Minneapolis, Minnesota, United States, 55435|
|Contact: Anne-Marie Tschida 952-922-7000 ext 4640 firstname.lastname@example.org|
|Principal Investigator: Tami Helmer, MD|
|Principal Investigator:||Richard E Golden, MD||Noran Neurological Clinic|
|Principal Investigator:||Tami Helmer, MD||Radiant Research|
|Responsible Party:||Todd Verdoorn, PhD, Chief Scientific Officer, Orasi Medical, Inc.|
|Other Study ID Numbers:||
TTD 10 - 01
|First Posted:||August 20, 2010 Key Record Dates|
|Last Update Posted:||March 23, 2011|
|Last Verified:||March 2011|
Nervous System Diseases