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No funding source
Sponsor study identifier
interventional
1
1 country
1
Study Start
December 10, 2018
Actual (reported)Primary Completion
July 26, 2021
Actual (reported)Study Completion
July 26, 2021
Actual (reported)There are numerous conditions that may benefit from TMS but they lack definitive data from clinical trials with sufficient scientific rigor, which includes large, multi-site, randomized sham-controlled trials. This is the status for a variety of psychiatric and neurological disorders such as tinnitus, central pain, movement disorders, stroke rehabilitation, obsessive compulsive disorders, anxiety, schizophrenia, and addiction. In certain instances there may be sufficient evidence supporting the treatment efficacy of TMS that it is reasonable to offer TMS as an off-label treatment, a term for clinical treatments that have not received FDA approval but may nonetheless be helpful for patients. In other cases there is such a paucity of clinical trial data that the use of therapeutic TMS is less appropriate as a clinical treatment that the patient is charged for out of pocket and may cost several thousand dollars, but is better suited for clinically-oriented research. This has the added benefit of potentially helping the patient and providing investigators with additional information from which to inform future clinical trials. In this study the investigators propose to use TMS to treat tinnitus, for which few other treatments currently exist. Tinnitus affects approximately 1% of the population and can be debilitating for patients. Recent studies have shown some promise in reducing symptoms through neuromodulation, but results are variable and more research is needed to improve treatment protocols. The investigators plan to contribute to this body of research by taking an evidence-based approach to test whether TMS is effective at reducing symptoms of tinnitus. Each subject's MRI will be used to perform neuronavigated TMS stimulations while documenting changes in symptom severity with self-report questionnaires and symptom severity scales. If it is determined that a stimulation protocol is effective, 1-2 weeks of daily treatments will be scheduled as part of that subject's personalized treatment plan.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 26, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2018
Actual (reported)October 9, 2018
Actual (reported)December 10, 2018
Actual (reported)July 26, 2021
Actual (reported)July 26, 2021
Actual (reported)July 11, 2023
Actual (reported)Clinical Improvement
Clinical Global Improvement Scale (0-7 scale where 0=not assessed, 1=Very much improved, and 7= Very much worse
End of treatment course - 5 days
Active TMS stimulation administered for tinnitus symptoms (no sham stimulation).
Targeted stimulation to decrease tinnitus symptom severity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Iowa
Iowa City, Iowa, 52242, United States
Aaron D Boes, MD, PhD
University of Iowa
1 participants (actual enrollment reported by the registry).
First Submitted
October 5, 2018
First Posted
October 9, 2018
Study Start
December 10, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 26, 2021
Actual (reported)Study Completion
July 26, 2021
Actual (reported)Last Updated
July 11, 2023
Results First Posted
July 11, 2023
Record last verified: 2023-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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