Tinnitus Measured by MEG and Synchronous Neural Interaction™ Test: Template Development

Tinnitus Clinical Trial

Official title:

Moderate to Severe Tinnitus as Measured by MEG and the Synchronous Neural Interaction™ Test: Template Development Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01185990
• Other study ID #: TTD 10 - 01
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2010
• Last updated: March 22, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2011
• Source: Orasi Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Tinnitus

Locations

Country	Name	City	State
United States	Noran Neurological Clinic	Minneapolis	Minnesota
United States	Radiant Research	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Orasi Medical, Inc.	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlated brain activity	MEG scan data will be analyzed using standard frequency domain approaches and the Orasi SNI test for correlated, synchronous activity.	1 day	No
Secondary	Tinnitus Severity Ratings	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.	Up to 14 days	No