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rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886938
First Posted: April 23, 2009
Last Update Posted: May 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University
  Purpose

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


Condition Intervention Phase
Tinnitus Device: Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study

Resource links provided by NLM:


Further study details as provided by Jay F. Piccirillo, MD, Washington University:

Primary Outcome Measures:
  • Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI) [ Time Frame: 0,4 weeks ]
    Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.


Enrollment: 12
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rTMS to DLPF, pilot study
rTMS to the dorsolateral prefrontal cortex for patients with tinnitus
Device: Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study
Repetitive transcranial magnetic stimulation, pilot study
Other Names:
  • Tinnitus
  • rTMS
  • Dorsolateral Prefrontal Cortex
  • DLPF
  • fcMRI

Detailed Description:
See description above.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886938


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jay F Piccirillo, MD,CPI Washington University School of Medicine
  More Information

Responsible Party: Jay F. Piccirillo, MD, Professor, Washington University School of Medicine, Washington University
ClinicalTrials.gov Identifier: NCT00886938     History of Changes
Other Study ID Numbers: 09-0551
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: March 7, 2012
Results First Posted: May 21, 2012
Last Update Posted: May 16, 2014
Last Verified: May 2014

Keywords provided by Jay F. Piccirillo, MD, Washington University:
tinnitus

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