CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00329524
NCT00329524N/ACompleted

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

University of Arkansas·interventional·Posted May 24, 2006·Updated May 4, 2015

In Brief

A clinical study evaluating Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2006
Enrollment StartJun 1, 2006
Primary CompletionJun 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.1 years ago

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)device

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.