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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Orasi Medical, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
Orasi Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01185990
First received: August 17, 2010
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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.


Condition
Tinnitus

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Orasi Medical, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 45
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)
Groups/Cohorts
Tinnitus subjects
Subjects with chronic, moderate to severe unilateral tinnitus.
Healthy control subjects

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects with chronic, moderate to severe unilateral tinnitus

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185990

Locations
United States, Minnesota
Noran Neurological Clinic Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Ann Rechtzigel, BSN    612-708-5357    rex5@frontiernet.net   
Principal Investigator: Richard E Golden, MD         
Radiant Research Recruiting
Minneapolis, Minnesota, United States, 55435
Contact: Anne-Marie Tschida    952-922-7000 ext 4640    anne-marietschida@radiantresearch.com   
Principal Investigator: Tami Helmer, MD         
Sponsors and Collaborators
Orasi Medical, Inc.
Novartis
Investigators
Principal Investigator: Richard E Golden, MD Noran Neurological Clinic
Principal Investigator: Tami Helmer, MD Radiant Research
  More Information

No publications provided

Responsible Party: Todd Verdoorn, PhD, Chief Scientific Officer, Orasi Medical, Inc.
ClinicalTrials.gov Identifier: NCT01185990     History of Changes
Other Study ID Numbers: TTD 10 - 01
Study First Received: August 17, 2010
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014