Tinnitus Measured by MEG and Synchronous Neural Interaction™ Test: Template Development
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | August 2010 |
| End Date: | August 2011 |
Moderate to Severe Tinnitus as Measured by MEG and the Synchronous Neural Interaction™ Test: Template Development Study
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
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