Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus

Not Applicable

Completed

Brief Summary: One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the ear) ranging from mild to severe impairment. To date there is no effective therapy that seems to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate or reduce the symptoms of tinnitus.

This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with tinnitus that is severe enough for those persons to seek medical attention will have been seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine that acquires visual images of the brain). A diagnosis of tinnitus will be established after ruling out all other possible causes of the tinnitus.

Detailed Description: Subjects will be up to 20 right-handed patients (men and women), 19-65 years of age, with debilitating unilateral or bilateral tinnitus. All subjects must report experiencing the presence of their phantom auditory perception for at least 6 months and have a Tinnitus Handicap Questionnaire (THQ) score \>30. Subjects will be recruited from the Otolaryngology Clinic at UAMS, where routine testing includes a physical exam; pure tone audiometry; and evaluation of middle ear status using tympanometry, stapedius reflex tests, and otoscopy. Patients will undergo a gadolinium-contrast MRI of the head to rule out acoustic neuroma or any other central nervous system pathology. All subjects will be thoroughly informed of the risks associated with the procedures in this study, as described in the Hazards to Subjects section, and written informed consent will be obtained. Subjects will be recruited for this study without regard to race or ethnicity.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

significant neurological disease
acoustic neuromas or glomus tumors
active Meniere's disease
profound hearing loss
non English speaking
personal or family history of epilepsy
personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders, metal implants in the head or neck, a pacemaker, pregnancy, migraines,
medications that lower seizure threshold and are contraindicated
individuals who have been taking certain medications
claustrophobia
patients who do not exhibit significant cortical asymmetries on PET

Arm && Interventions

Group	Intervention	Description
Active versus Sham Treatment	Repetitive Transcranial Magnetic Stimulation (rTMS)	Subjects randomly assigned to active and sham TMS separated by one week interval.

Primary Outcome Measures

Name	Time	Method
Change in PET Asymmetry Index	After active treatment week	Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx

Secondary Outcome Measures

Name	Time	Method
Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx	immediately following active and sham TMS	Rating of tinnitus loudness using a scale of 0-100 for
Psychomotor Vigilance	Immediately after treatment	Change in simple auditory reaction time after treatment