Collaborative Tinnitus Research at Washington University
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Intervention: rTMS
Intervention description: Stimulation Settings:
Frequency -- 1Hz on 330 sec (5 min 30 sec.) per train for the first 5 trains with the last train 350 sec. (5 min. 50 sec.) in duration Off -- 90 sec (1 min. 30 sec.) Intensity -- 110% of motor threshold Duration -- 42½ minutes (total 2000 pulses in 6 trains)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: tinnitus; subjective tinnitus; therapy; repetitive transcranial magnetic stimulation; clinical trial

Summary:

      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.
    

Eligibility criteria:

        On-line eligibility screening:

        https://tinnitus.wustl.edu/

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.