Clinical trial NCT00329524: Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
Official title: Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
TMS
Transcranial Magnetic Stimulation
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Tinnitus Research Consortium
First posted: 2006-05-24
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* right-handed subjects
* 19-65 years of age
* debilitating unilaterial or bilateral tinnitus
* Experiencing the presence of phantom auditory preception for \>6 months
* Tinnitus Handicap Questionnaire score of \>30

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

Primary outcomes:
measure: Change in PET Asymmetry Index
timeFrame: After active treatment week
Secondary outcomes:
measure: Psychomotor Vigilance
timeFrame: Immediately after treatment
measure: Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx
timeFrame: immediately following active and sham TMS
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: John Dornhoffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith JA, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a pilot study. Laryngoscope. 2007 Mar;117(3):529-34. doi: 10.1097/MLG.0b013e31802f4154.
citation: Richter GT, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a case study. Laryngoscope. 2006 Oct;116(10):1867-72. doi: 10.1097/01.mlg.0000234936.82619.69.