Brain Imaging of Tinnitus

NCT00359931 | Completed

• 2 other identifiers: 06021806-DC-0218
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use magnetic resonance imaging (MRI) to compare brain function in three groups of people: hearing-impaired people with tinnitus; hearing-impaired people without tinnitus; and people with normal hearing and without tinnitus. Also known as "ringing in the ears," tinnitus is the false sensation of sounds. Adults between 30 and 65 years of age who meet the following criteria may be eligible for this study:

• Mild to moderate hearing loss who have experienced tinnitus daily for at least 1 year
• Mild to moderate hearing loss who have never or rarely experienced tinnitus
• Normal hearing who have never or rarely experienced tinnitus Candidates are screened with a medical history and questionnaires. Participants have a detailed hearing test to measure hearing and the nature of tinnitus. In a second visit, subjects have a brief physical examination, followed by MRI scanning. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The subject may be asked to lie still for up to 8 minutes at a time. During the MRI, the subject performs computer-based tasks that involve listening to sounds. Another hearing test is done after the MRI.

Conditions

Hearing Disorder

Keywords

Neural Networks; Mathematical Modeling; Auditory Processing; Tinnitis; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• The primary hypothesis is that a network of brain regions, from auditory processing areas to emotional processing areas, contributes to, and modulates, tinnitus perception.

  ongoing

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plus Tinnitus Plus Hearing loss subjects.
• Adults, between the ages of 30 to 65 years.
• Are able to hear and perceive sounds used in the experiment in the range 250 Hz to 2 KHz and have high-frequency sensorineural hearing loss beginning no lower than 2 KHz.
• In good health and not currently taking certain medications regularly (e.g. antidepressants, antiseizure medications, antipsychotics, etc.).
• Experience tinnitus daily.
• Have had non-pulsatile tinnitus for at least 1 year.
• Have bilateral or bilateral with unilateral dominance tinnitus.
• Minus Tinnitus Plus Hearing loss subjects.
• Adults, between the ages of 30 to 65 years.
• Are able to hear and perceive sounds used in the experiment in the range 250 Hz to 2 KHz and have high-frequency sensorineural hearing loss beginning no lower than 2 KHz.
• In good health and not currently taking certain medications regularly (e.g. antidepressants, antiseizure medications, antipsychotics, etc.).
• Have never or rarely (i.e. transient episodes experienced by virtually everyone) experienced tinnitus.
• Minus Tinnitus Minus Hearing loss subjects or normal volunteers.
• Adults, between the ages of 30 to 65 years.
• Have normal hearing.

You may not qualify if:

• Subjects who have pacemakers, aneurysm clips, metallic prostheses or shrapnel fragments.
• Subjects incapable of giving informed consent.
• Subjects with a positive pregnancy test.
• Children below the age of 18 years.
• Subjects with hyperacusis or misophonia (hyper-sensitivity to loud noises).
• Subjects with mood disturbances such as depression or anxiety.
• Subjects with a history of temporomandibular joint problems or who present symptoms of pain and tenderness of the temporomandibular joint on examination.
• Subjects may be excluded for the following reasons that may cause difficulty with interpretation of the imaging data:
• Subjects with mental or physical illnesses, other than tinnitus that may cause problems with participation in the study.
• Subjects with current uncontrolled hypertension, or significant past history of cardiovascular disease and diabetes melitus.
• Subjects with a history of head trauma with loss of consciousness, epilepsy, seizures, a history of chemotherapy (neurotoxic or ototoxic) and other medical conditions that may alter cerebral functioning.
• Subjects who are taking or have a history of taking recreational drugs or alcoholism.
• Subjects with unilateral or asymmetrical hearing loss who have not had (or cannot provide documentation of) comprehensive neuro-otologic workup will be excluded.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Mirz F, Gjedde A, Sodkilde-Jrgensen H, Pedersen CB. Functional brain imaging of tinnitus-like perception induced by aversive auditory stimuli. Neuroreport. 2000 Feb 28;11(3):633-7. doi: 10.1097/00001756-200002280-00039.

  PMID: 10718327 BACKGROUND

• Giraud AL, Chery-Croze S, Fischer G, Fischer C, Vighetto A, Gregoire MC, Lavenne F, Collet L. A selective imaging of tinnitus. Neuroreport. 1999 Jan 18;10(1):1-5. doi: 10.1097/00001756-199901180-00001.

  PMID: 10094123 BACKGROUND

• Mirz F, Gjedde A, Ishizu K, Pedersen CB. Cortical networks subserving the perception of tinnitus--a PET study. Acta Otolaryngol Suppl. 2000;543:241-3. doi: 10.1080/000164800454503.

  PMID: 10909031 BACKGROUND

MeSH Terms

Conditions

Hearing Disorders; Hearing Loss

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barry Horwitz, Ph.D.

  National Institute on Deafness and Other Communication Disorders (NIDCD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2006
• First Posted: August 3, 2006
• Study Start: July 28, 2006
• Study Completion: March 7, 2016
• Last Updated: October 6, 2017

Record last verified: 2016-03-07

Locations

US (1)