Collaborative Tinnitus Research at Washington University

Completed · Phase 2 · Has a placebo group

Conditions studied: Subjective Tinnitus

In brief

The goal of this trial to see if repetitive transcranial magnetic stimulation (rTMS) to the hearing area of the brain can lessen the perception of tinnitus. rTMS uses a strong magnet and when placed against the scalp generates a small electrical field within the brain. Depending on the frequency of the stimulation, this electrical field can either decrease or increase the electrical excitability of the brain. In this study, low-frequency stimulation will be used, which is thought to decrease nerve activity. It is this electrical excitability of the brain that is thought to be responsible for tinnitus. The hypothesis of this study is that rTMS can decrease the perception of tinnitus.

Key facts

Study ID

NCT00567892

Run by

Washington University School of Medicine

People needed

55

Starts

2008-01-01

Expected to finish

2011-06-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women between the ages of 18 and 60 years.
• Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater.
• Tinnitus Handicap Inventory (THI) score of 38 or greater.
• Subjects of child-bearing potential using an appropriate form of birth control acceptable to the research team and with a negative urine pregnancy test or undergone sterilization procedure.
• Able to give informed consent.
• Available for once daily therapy, during working hours, Mon.-Fri.
• English-speaking.

You may not qualify if…

• Patients experiencing tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone.
• Patients with hyperacusis or misophonia (hyper-sensitivity to loud noises).
• History of seizures, history of loss of consciousness requiring medical care, any other CNS pathology that increases a subject's risk for treatment with rTMS.
• Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, other intracranial metal objects with the exception of dental fillings, or any other contraindication for MRI scan.
• Any contraindication for receiving FDG PET, as determined by established clinical criteria.
• Patients with an acute or chronic unstable medical condition which, in the opinion of the investigator, would require stabilization prior to initiation of magnetic stimulation.
• Patients with any active ear disease that, in the opinion of the PI, needs to be further evaluated.
• Patients with symptoms of depression as evidenced by a score of 14 or greater on the Beck Depression Inventory or, in the opinion of the psychiatric sub-investigator demonstrates active mood symptoms that meet DSM-IV-TR criteria for Major Depressive Disorder.
• Any psychiatric co-morbidity that, in the opinion of the psychiatric sub-investigator, may complicate the interpretation of study results.
• Pregnancy
• Currently breast-feeding
• Previous treatment with rTMS
• Patients with tinnitus related to Workman's Compensation claim or litigation-related event.
• Patients with a history of diabetes.
• Fasting glucose > 150mg/Dl.
• Patients taking any medication(s), in the opinion of the investigator, that is(are) deemed to be etiologically related to the development of tinnitus.
• Unable to elicit a motor threshold with rTMS.
• A Mini-Mental Status Exam score less than 27.
• Untreated or newly diagnosed hypertension, (systolic blood pressures above 140 mm or diastolic pressure above 90 mm).
• Patients with a history of claustrophobia.
• Inability to lay flat for 2 hours.
• Active alcohol and/or drug dependence or history of alcohol and/or ETOH dependence within the last year.
• Any medical condition that, in the opinion of the investigators, confounds study results or places the subject at greater risk.
• Unable to provide informed consent.
• Any exclusions from radiology screening for MRI or PET scanning.

Where it is running

• Washington University Medical Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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