rTMS Bimodal Treatment For Tinnitus: A Pilot Study

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.

Recent exciting work in schizophrenia used a bimodal (DLPFC and TPC) treatment approach in
pharmacologically non-responsive patients. The study used high-frequency stimulation to the
left DLPFC and low-frequency stimulation to the left TPC. Bimodal rTMS stimulation of left
DLPFC and left TPC induced clinical improvement in pharmacologically non-responsive
schizophrenia patients and may have improved their short-term verbal memories.57

Inclusion Criteria:

- Must be between the ages of 18 and 60 years.

- Subjective, idiopathic, troublesome, unilateral or bilateral, non-pulsatile tinnitus
of ≥ 2 month's duration but no greater than 5 year's duration.

- Bothersome Tinnitus according to Tinnitus Handicap Inventory score.

- Must be able to understand, speak, read and write English proficiently

- Able to provide informed consent

- Women who are of childbearing potential must agree to use a medically acceptable form
of birth control and must have a negative urine pregnancy test at screening

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 will be excluded.

- Hypersensitive to noises (hyperacusis)

- Patients with history of head injury with 15 minutes or more loss of
consciousness or required medical treatment.

- 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.

- 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, pneumonia, 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 moderate to severe clinical depression as evidenced by a score of
15 or greater on the PHQ-9.

- Patients who, in the opinion of the psychiatric sub-investigator, demonstrate
moderate to severe depressive symptoms according to DSM-IV-TR criteria for Major
Depressive Disorder.

- Patients with psychiatric illness or trauma which would prohibit participation
in the study.

- Patients with active psychotic symptoms or a history of psychotic disorder

- 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 whose ability to give informed consent is in question

- Undiagnosed symptomatic hypertension: .

- Undiagnosed asymptomatic hypertension:

- Any patient who has scheduled an elective surgery or change in medication during
the 5 weeks of the study.

- Use of Neuromonics Device during duration of study or currently in Tinnitus
Retraining Program during course of study.

- Any medical condition that, in the opinion of the investigators, confounds study
results or places the subject at greater risk.

- Patients currently taking psychotropic medications including antidepressants,
benzodiazepines, anticonvulsants, stimulants, antipsychotics, or anxiolytics.

- Tinnitus related to a Workman's Compensation claim or litigation-related event
that is still pending.