Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

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.
    

Detailed description: 
      Subjects will be up to 20 right-handed patients (men and women), 19-65 years of age, with
      debilitating unilateral or bilateral tinnitus. All subjects must report experiencing the
      presence of their phantom auditory perception for at least 6 months and have a Tinnitus
      Handicap Questionnaire (THQ) score >30. Subjects will be recruited from the Otolaryngology
      Clinic at UAMS, where routine testing includes a physical exam; pure tone audiometry; and
      evaluation of middle ear status using tympanometry, stapedius reflex tests, and otoscopy.
      Patients will undergo a gadolinium-contrast MRI of the head to rule out acoustic neuroma or
      any other central nervous system pathology. All subjects will be thoroughly informed of the
      risks associated with the procedures in this study, as described in the Hazards to Subjects
      section, and written informed consent will be obtained. Subjects will be recruited for this
      study without regard to race or ethnicity.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tinnitus; TMS; Transcranial Magnetic Stimulation