Tinnitus
Conditions
Keywords
Tinnitus, TMS, Transcranial Magnetic Stimulation
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if a maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectively, 7 days following the completion of the first treatment session.
Sponsors
Tinnitus Research Consortium
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor Vigilance | Immediately after treatment | Change in simple auditory reaction time after treatment |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Versus Sham TMS Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Active Versus Sham TMS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in PET Asymmetry Index
Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx
Time frame: After active treatment week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Versus Sham TMS | Change in PET Asymmetry Index | 1.2 ratio | Standard Deviation 2.3 |
Secondary
Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx
Rating of tinnitus loudness using a scale of 0-100 for
Time frame: immediately following active and sham TMS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Versus Sham TMS | Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx | 2.5 analog rating | Standard Deviation 1.2 |
p-value: 0.05test for order effect
Secondary
Psychomotor Vigilance
Change in simple auditory reaction time after treatment
Time frame: Immediately after treatment
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Versus Sham TMS | Psychomotor Vigilance | -30 milliseconds | Standard Deviation 18.27 |
p-value: <0.05t-test, 2 sided