Using PET-CT to Target and Validate Low-Frequency TMS as Treatment for Tinnitus

This study has been completed.
Sponsor:
Collaborator:
Tinnitus Research Consortium
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00329524
First received: May 22, 2006
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Tinnitus
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Using PET-CT to Target and Validate Low-Frequency TMS as Treatment for Tinnitus

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Change in PET Asymmetry Index [ Time Frame: After active treatment week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychomotor Vigilance [ Time Frame: Immediately after treatment ] [ Designated as safety issue: Yes ]
  • Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx [ Time Frame: immediately following active and sham TMS ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: June 2006
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Active versus Sham Treatment
Subjects randomly assigned to active and sham TMS separated by one week interval.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • right-handed subjects
  • 19-65 years of age
  • debilitating unilaterial or bilateral tinnitus
  • Experiencing the presence of phantom auditory preception for >6 months
  • Tinnitus Handicap Questionnaire score of >30

Exclusion Criteria:

  • significant neurological disease
  • acoustic neuromas or glomus tumors
  • active Meniere's disease
  • profound hearing loss
  • non English speaking
  • personal or family history of epilepsy
  • personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders, metal implants in the head or neck, a pacemaker, pregnancy, migraines,
  • medications that lower seizure threshold and are contraindicated
  • individuals who have been taking certain medications
  • claustrophobia
  • patients who do not exhibit significant cortical asymmetries on PET
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329524

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Tinnitus Research Consortium
Investigators
Principal Investigator: John Dornhoffer, MD University of Arkansas
  More Information

Publications:
Responsible Party: Carole Hamon, The University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00329524     History of Changes
Other Study ID Numbers: 51817
Study First Received: May 22, 2006
Results First Received: June 17, 2009
Last Updated: June 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Tinnitus
TMS
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014