N/A
N=5
Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT00329524 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcome: Primary: Change in PET Asymmetry Index — 1.2 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PET Asymmetry Index |
1.2 | — |
| SECONDARY Psychomotor Vigilance |
-30 | <.05 sig |
| SECONDARY Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx |
2.5 | .05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00329524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.