Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
|ClinicalTrials.gov Identifier: NCT00329524|
Recruitment Status : Completed
First Posted : May 24, 2006
Results First Posted : August 7, 2009
Last Update Posted : May 4, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: Repetitive Transcranial Magnetic Stimulation (rTMS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||August 2008|
Sham Comparator: Active versus Sham Treatment
Subjects randomly assigned to active and sham TMS separated by one week interval.
Device: Repetitive 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.
- Change in PET Asymmetry Index [ Time Frame: After active treatment week ]Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx
- Psychomotor Vigilance [ Time Frame: Immediately after treatment ]Change in simple auditory reaction time after treatment
- Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx [ Time Frame: immediately following active and sham TMS ]Rating of tinnitus loudness using a scale of 0-100 for
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329524
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||John Dornhoffer, MD||University of Arkansas|