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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00567892 |
The goal of this trial to see if repetitive transcranial magnetic stimulation (rTMS) to the hearing area of the brain can lessen the perception of tinnitus. rTMS uses a strong magnet and when placed against the scalp generates a small electrical field within the brain. Depending on the frequency of the stimulation, this electrical field can either decrease or increase the electrical excitability of the brain. In this study, low-frequency stimulation will be used, which is thought to decrease nerve activity. It is this electrical excitability of the brain that is thought to be responsible for tinnitus.
The hypothesis of this study is that rTMS can decrease the perception of tinnitus. Each participant will initially receive either active rTMS or sham rTMS (placebo) for 2 weeks. After the 2 weeks, the participant will rest for 2 weeks. After the 2 week rest, the participant will then receive either active rTMS or sham rTMS, depending on what they received during the first 2 weeks. The order of the treatments received will be randomly selected and the participant will not be told which treatment they are receiving. Each participant will undergo magnetic resonance imaging (MRI) and positive emission tomography (PET) scanning of the brain at the beginning of the study and after each treatment.
Condition | Intervention | Phase |
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Subjective Tinnitus |
Device: rTMS |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Collaborative Tinnitus Research at Washington University |
Estimated Enrollment: | 55 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. rTMS: Experimental
Stimulation Settings: Frequency -- 1Hz on 330 sec (5 min 30 sec.) per train for the first 5 trains with the last train 350 sec. (5 min. 50 sec.) in duration Off -- 90 sec (1 min. 30 sec.) Intensity -- 110% of motor threshold Duration -- 42½ minutes (total 2000 pulses in 6 trains) |
Device: rTMS
Stimulation Settings: Frequency -- 1Hz on 330 sec (5 min 30 sec.) per train for the first 5 trains with the last train 350 sec. (5 min. 50 sec.) in duration Off -- 90 sec (1 min. 30 sec.) Intensity -- 110% of motor threshold Duration -- 42½ minutes (total 2000 pulses in 6 trains) |
2. Sham: Sham Comparator
Sham appears identical to and mimics sounds and sensations of active magnet.
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Device: rTMS
Stimulation Settings: Frequency -- 1Hz on 330 sec (5 min 30 sec.) per train for the first 5 trains with the last train 350 sec. (5 min. 50 sec.) in duration Off -- 90 sec (1 min. 30 sec.) Intensity -- 110% of motor threshold Duration -- 42½ minutes (total 2000 pulses in 6 trains) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
On-line eligibility screening:
http://tinnitus.wustl.edu/
Inclusion Criteria:
Exclusion Criteria:
Contact: Joyce Nicklaus, RN, BSN | 314.362.7508 | nicklausj@ent.wustl.edu |
United States, Missouri | |
Washington University Medical Center | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Joyce Nicklaus, RN,BSN 314-362-7508 nicklausj@ent.wustl.edu | |
Principal Investigator: Jay F Piccirillo, MD |
Principal Investigator: | Jay F Piccirillo, MD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Jay F. Piccirillo ) |
Study ID Numbers: | 07-0689, R01DC009095 |
Study First Received: | December 3, 2007 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00567892 |
Health Authority: | United States: Federal Government |
tinnitus subjective tinnitus therapy repetitive transcranial magnetic stimulation clinical trial |
Signs and Symptoms Sensation Disorders Hearing Disorders Otorhinolaryngologic Diseases |
Neurologic Manifestations Ear Diseases Tinnitus |
Nervous System Diseases |