Transcranial Magnetic Stimulation for Tinnitus

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Tinnitus

In brief

The purpose of this study is to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for reducing the loudness or severity of chronic tinnitus.

Key facts

Study ID

NCT01104207

Run by

VA Office of Research and Development

People needed

70

Starts

2011-03-01

Expected to finish

2016-12-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic tinnitus.
• Able to provide written informed consent.
• Subject is naive regarding rTMS.
• Age/Gender: minimum 18 years old, with an attempt to sample equal numbers of male and female subjects.
• Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study.
• Other medications: No restrictions, provided the dosages have been in place for at least 6 months.
• Psychological status: Stable enough to complete this study per the opinion of the Study Physician.
• Hearing function: All degrees of hearing function can be included recognizing that profound, bilateral losses will not be able to perform tinnitus evaluations and hearing tests, but will be able to rate subjective tinnitus loudness, annoyance and impact on life. This is an important subpopulation because of the challenges in treating them with acoustic therapy and the need for a medical intervention.
• Tinnitus characteristics: All forms of tinnitus etiology will be accepted, providing the following criteria are met:
• Tinnitus duration: Not less than 1 year. Cases of less than 1 year duration have increased likelihood of resolving spontaneously.
• Stability: Constant (not pulsatile, intermittent, varying to a high degree in loudness or changing in location of perception). Fluctuating tinnitus reduces the reliability of test-retest measures for loudness.
• Self-rated tinnitus loudness: >= 6 on a visual numerical scale (VNS: 0 labeled "No Tinnitus", 10 labeled "Very Loud"). This outcome measure will provide a subjective indication of immediate changes in perceived loudness.
• Location of tinnitus perception: Unrestricted. Tinnitus may be unilateral, bilateral, or perceived in the head.

You may not qualify if…

• Medical conditions: No active neurologic or otologic disease processes that may impact tinnitus perception. No auto-immune diseases. No pregnancy or planned pregnancy during the study. No women who are lactating or are of child-bearing-age without using contraception.
• Objective Tinnitus - tinnitus that is audible to other people in addition to the patient. This type of tinnitus is rare and is unlikely to respond to rTMS because it is not associated with abnormal neural activity in the central auditory system.
• History or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events (such as strokes), neurodegenerative disorders affecting the brain (such as Parkinson's Disease, ALS, Huntington's Disease or Multiple Sclerosis) or prior brain surgery.
• Cardiac pace makers, other electronic implants (including cochlear implants), intracranial or intraocular metallic particles.
• History of seizures or epileptic activity.
• Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the trial.
• Participation in a clinical trial within the last 30 days before the start of this one.
• Maximum number of previous clinical trials for tinnitus in which subjects may have participated: two.

Where it is running

• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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