Effect of rTMS on Resting State Brain Activity in Tinnitus
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ClinicalTrials.gov Identifier: NCT00926237 |
Recruitment Status
:
Recruiting
First Posted
: June 23, 2009
Last Update Posted
: October 4, 2017
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Tracking Information | |||||||||
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First Submitted Date ICMJE | June 19, 2009 | ||||||||
First Posted Date ICMJE | June 23, 2009 | ||||||||
Last Update Posted Date | October 4, 2017 | ||||||||
Study Start Date ICMJE | January 2009 | ||||||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change in tinnitus perception, as measured over time using a subjective visual analog rating scale [ Time Frame: At subject enrollment, before and after each active or sham rTMS session, inbetween active and sham treatments, and 2 months following the end of treatment. ] | ||||||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00926237 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Effect of rTMS on Resting State Brain Activity in Tinnitus | ||||||||
Official Title ICMJE | Effect of rTMS on Resting State Brain Activity in Tinnitus | ||||||||
Brief Summary | One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in the ear) ranging from mild to severe impairment. To date, there are no effective therapies available that have been shown to decrease tinnitus loudness. The purpose of this study is to develop a new treatment option for tinnitus using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS), which will hopefully prove to be an effective means of alleviating or reducing the symptoms of tinnitus. | ||||||||
Detailed Description | This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to 60 subjects, including males and females ages 19-89 years old and of all races, and with tinnitus severe enough to seek medical attention, will be enrolled in this study. All participants will be evaluated or medically reviewed by the study physician, Dr. Dornhoffer of the Hearing and Balance Clinic at UAMS, including a modified physical examination and hearing tests, prior to beginning therapy with rTMS in order to rule out any medically treatable causes of tinnitus. An MRI scan of the head may or may not be required, depending upon the results of this evaluation, in order to rule out specific middle ear pathologies. This study will require participation in at least three weeks (4 weekdays per week) of rTMS sessions, including two active weeks and a sham (or placebo) week. There will be a three week washout period following each treatment week. At the completion of the three treatment weeks, subjects who have noticed an improvement in their tinnitus will have the option of participating in a maintenance rTMS program providing up to 8 additional weeks of treatment. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Tinnitus | ||||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE |
10 | ||||||||
Estimated Study Completion Date | September 2020 | ||||||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 19 Years to 89 Years (Adult, Senior) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00926237 | ||||||||
Other Study ID Numbers ICMJE | 109033 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | University of Arkansas | ||||||||
Study Sponsor ICMJE | University of Arkansas | ||||||||
Collaborators ICMJE | National Institutes of Health (NIH) | ||||||||
Investigators ICMJE |
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PRS Account | University of Arkansas | ||||||||
Verification Date | October 2017 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |