rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study
Intervention description: Repetitive transcranial magnetic stimulation, pilot study
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: tinnitus

Summary:

      The neurological basis of tinnitus is uncertain when there is no evidence of damage to the
      peripheral auditory system. However, neuroimaging studies of tinnitus patients show
      hyperactivity in several cortical regions, especially the auditory cortices and middle
      temporal regions. A potentially promising treatment modality for tinnitus is repetitive
      transcranial magnetic stimulation (rTMS). rTMS involves the application of frequent, repeated
      magnetic stimuli to the skull to induce electrical activity in the underlying cortical areas
      of the brain. When the magnetic device is placed on the skull, the resultant magnetic field
      passes through the skull and induces a small secondary current in the cortex. It has been
      hypothesized that the effect of the frequency used in rTMS differentially influences cortical
      activity with low-frequency (1Hz) stimulation decreasing and high-frequency stimulation
      (10-20 Hz) increasing cortical activity.

      Currently, reports on treating tinnitus with rTMS have focused on low-frequency stimulation
      of the left auditory cortex, an area that has been demonstrated to be hyperactive in
      tinnitus. The benefits of low-frequency auditory cortex stimulation are time limited however.
      Converging data implicate structures of the brain that are important for mood and attention
      as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment
      approach that targets these structures. A growing number of studies demonstrate involvement
      of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in
      the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal
      cortex has been shown to increase the durability of the TPC stimulation. The independent
      effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that
      increasing the intensity and duration of stimulation has beneficial treatment effects.
      However, the field is new and more work is needed to assess the effectiveness of this
      treatment, predictors and correlates of response, and safety.

      Herein, we propose an open-label pilot study investigating the effectiveness of rTMS
      stimulation of the dorsolateral prefrontal cortex, an area known to be important for mood and
      attention, in the treatment of tinnitus
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between the ages of 18 and 60 years.

          -  Subjective, idiopathic, troublesome, unilateral or bilateral, non-pulsatile tinnitus
             of ≥ 6 month's duration..

          -  Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.

          -  Must be able to understand, speak, read, and write English proficiently

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or
             other known anatomic/structural lesions of the ear and temporal bone. Patients with a
             history of stapedectomy and insertion of implant may be included if their prosthesis
             is magnetically safe (MRI compatible up to and including 3T). Patient must be able to
             provide documentation from surgeon regarding manufacturer information of prosthesis
             before they will be considered into study.

          -  Hypersensitive to noises (hyperacusis)

          -  Patients with cardiac pacemakers; intracardiac lines; implanted medication pumps;
             implanted electrodes in the brain; other implanted electrical or magnetic medical
             devices; or other intracranial metal objects or shrapnel, with the exception of dental
             fillings and MRI compatible stapedectomies or any other contraindication for MRI scan

          -  Patients with additional significant neurological disorders including increased
             intracranial pressure, brain mass, epileptic seizures (or family history of epileptic
             seizures), history of stroke, transient ischemic attack within 2 years, cerebral
             aneurysm, Huntington's chorea or multiple sclerosis.

          -  Patients with an acute or unstable medical condition including all patients with any
             significant heart disease, heart murmur, pneumonia, acute GI bleed, uncontrolled
             hypertension, or other disorders which would require stabilization prior to initiation
             of transcranial magnetic stimulation.

          -  Active alcohol and/or drug dependence or history of alcohol and/or drug dependence
             within the last year.

          -  Patients with clinical depression as evidenced by a score of 18 or greater on the Beck
             Depression Inventory98 or who or, in the opinion of the psychiatric sub-investigator
             demonstrates active mood symptoms that meet DSM-IV-TR criteria for Major Depressive
             Disorder

          -  Patients with psychological illness or trauma which would prohibit participation in
             the study.

          -  Female patients of child-bearing potential, unless sterilized or using an appropriate
             form of birth control acceptable to the research team.

          -  Currently breastfeeding

          -  Currently pregnant

          -  Patients will be excluded if a motor threshold cannot be elicited

          -  Patients who or are taking over-the-counter or prescribed medication administered for
             the treatment of any psychiatric or neurologic disorder or any other known CNS active
             drugs, including herbal, over-the-counter, and homeopathic medications, MAOIs, other
             antidepressants, antipsychotics, and mood stabilizers.

          -  Patients whose ability to give informed consent is in question

          -  Undiagnosed symptomatic hypertension: (for this study defined as systolic blood
             pressures above 140 mm or diastolic pressure above 90 mm). Subject will be referred to
             their PCP and not allowed to continue in screening without a note from the PCP stating
             that they are under his care and have been asymptomatic and with subject's
             hypertension controlled for at least 3 months.

          -  Undiagnosed asymptomatic hypertension: (for this study defined as systolic blood
             pressures above 140 mm or diastolic pressure above 90 mm). Subject will be allowed to
             continue in the screening process at the discretion of the PI. However, the subject
             will be referred to his PCP and not allowed to start treatment without a note from his
             PCP stating that either he was evaluated and his blood