TinnitusNCT01185990
Tinnitus Measured by MEG and Synchronous Neural Interaction™ Test: Template Development
An observational study of Tinnitus, run by Orasi Medical, Inc. at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with chronic, moderate to severe unilateral tinnitus
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Noran Neurological Clinic
Minneapolis, Minnesota, 55407
Ann Rechtzigel, BSN, 612-708-5357, rex5@frontiernet.net
Richard E Golden, MD
- Recruiting
Radiant Research
Minneapolis, Minnesota, 55435
Anne-Marie Tschida, 952-922-7000 ext. 4640, anne-marietschida@radiantresearch.com
Tami Helmer, MD
About this study
Official title: 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.
- Conditions
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tinnitus subjects | Subjects with chronic, moderate to severe unilateral tinnitus. | |
| Healthy control subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlated brain activity
MEG scan data will be analyzed using standard frequency domain approaches and the Orasi SNI test for correlated, synchronous activity.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orasi Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Investigators
- Richard E Golden, MD, Principal investigator, Noran Neurological ClinicTami Helmer, MD, Principal investigator, Radiant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185990
- Sponsor's protocol ID
- TTD 10 - 01
- Status last verified
- Mar 2011
- First submitted
- 17 Aug 2010
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate to Severe Tinnitus as Measured by MEG and the Synchronous Neural Interaction™ Test: Template Development Study
- ClinicalTrials.gov ID
- NCT01185990
- Acronym / sponsor ID
- TTD 10 - 01
- Conditions
- Tinnitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Orasi Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tinnitus subjects | – | –Subjects with chronic, moderate to severe unilateral tinnitus. |
| Healthy control subjects | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic, moderate to severe unilateral tinnitus
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Tinnitus Severity Ratings
Time frame: Up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radiant Research
Minneapolis, United States
Richard E Golden, MD principal investigator
Noran Neurological Clinic
Tami Helmer, MD principal investigator
Radiant Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Orasi Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlated brain activity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011; AzTrials last refreshed its copy on 6 Nov 2026.