Status:
UNKNOWN
Tinnitus Measured by MEG and Synchronous Neural Interaction™ Test: Template Development
Lead Sponsor:
Orasi Medical, Inc.
Collaborating Sponsors:
Novartis
Conditions:
Tinnitus
Eligibility:
All Genders
18-75 years
Brief Summary
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 identi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01185990
Start Date
August 1 2010
End Date
August 1 2011
Last Update
March 23 2011
Active Locations (2)
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1
Noran Neurological Clinic
Minneapolis, Minnesota, United States, 55407
2
Radiant Research
Minneapolis, Minnesota, United States, 55435