Tinnitus Clinical Trials Information as of March 15, 2014 TELEPHONE TINNITUS EDUCATION FOR PATIENTS WITH TRAUMATIC BRAIN INJURY (NCT01129141) This study will develop and evaluate an adaptation of Progressive Tinnitus Management (PTM) for use as a telephone-based program for veterans and military personnel who have experienced TBI. Lead Sponsor: Department of Veterans Affairs Status: Recruiting Participants Location: Portland, OR – VA Medical Center, Portland TRANSCRANIAL MAGENTIC STIMULATION FOR TINNITUS (NCT01104207) To assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for reducing the loudness or severity of chronic tinnitus. Lead Sponsor: Department of Veterans Affairs Status: Phase 1 & Phase 2 – Recruiting Participants Location: Portland, OR – VA Medical Center, Portland VAGUS NERVE STIMULATION (VNS) PAIRED WITH TONES FOR TINNITUS (NCT01962558) The purpose of this study is to investigate the effectiveness and safety of Vagus Nerve Stimulation (VNS) used with tones (the Serenity System) in the treatment of tinnitus. Lead Sponsor: MicroTransponder, Inc. Status: Recruiting Participants Location: Buffalo, NY – The University of Buffalo, State University of New York Dallas, TX – University of Texas, Dallas Iowa City, IA – University of Iowa PILOT STUDY OF DEEP BRAIN STIMULATION (DBS) IN AREA LC FOR CHRONIC TINNITUS (NCT01988688) This study will test the safety and efficacy of deep brain stimulation (DBS) for patients with bothersome and very bothersome tinnitus. Lead Sponsor: Paul Larson, MD, University of California, San Francisco Status: Phase 1 – Recruiting Participants Location: San Francisco, CA – San Francisco Veterans’ Administration Medical Center Around the country, researchers are busy looking for better treatments and cures for tinnitus. Here’s a small sample of the tinnitus-related clinical trials currently active in the United States. Please note: this information was gathered through ClinicalTrials.gov, a service of the U.S. National Institutes of Health, and is for general informational purposes only. Individuals are encouraged to visit ClinicalTrials.gov for full study details, updated information, and participation criteria. (Search for a trial using the NCT number, listed after each study title.) 26 Tinnitus Today | Spring 2014 OTO-104 FOR THE TREATMENT OF MENIERE’S DISEASE (NCT01412177) To evaluate the effectiveness of the drug OTO-104 for the treatment of Meniere’s Disease Lead Sponsor: Otonomy, Inc. Status: Phase 2 – Recruiting Participants Location: Nationwide TINNITUS RETRAINING THERAPY TRIAL (NCT01177137) To assess the efficacy of Tinnitus Retraining Therapy (TRT), a nonmedical intervention that uses directive counseling and sound therapy to habituate the patient’s associated negative emotional reactions to tinnitus. Lead Sponsor: Johns Hopkins Bloomberg School of Public Health Status: Phase 3 - Recruiting Participants Locations: Camp Pendleton, CA – Naval Hospital Camp Pendleton San Diego, CA – Naval Medical Center Travis AFB, CA – David Grant Medical Center Bethesda, MD – Walter Reed National Military Medical Center Lackland AFB, TX – Wilford Hall Medical Center Portsmouth, VA – Portsmouth Naval Medical Center INVESTIGATING THE NEUROBIOLOGY OF TINNITUS (NCT01294124) To determine if soldiers who develop tinnitus display predeployment differences in comparison to soldiers who do not develop tinnitus. Researchers will study a set of physical, functional, cognitive, vulnerability, and perpetuating factors, as well as pre-deployment neurocognitive scores, or neuroimaging features. EFFECT OF RTMS ON RESTING STATE BRAIN ACTIVITY IN TINNITUS (NCT00926237) The purpose of this study is to explore Repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment option to alleviate or reduce tinnitus symptoms. Lead Sponsor: Washington University School of Medicine Status: Not yet open for participant recruitment Locations: San Diego, CA – Naval Medical Center St. Louis, MO – Washington University School of Medicine Lead Sponsor: University of Arkansas Status: Recruiting Participants Location: Little Rock, AR – University of Arkansas for Medical Sciences Learn more at: ClinicalTrials.gov SCIENCE & RESEARCH NATIONWIDE
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