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Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
NA trial testing TMS for tinnitus in Tinnitus in 1 participant. Terminated before completion.
| Lead sponsor | Aaron Boes |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 10 December 2018 |
| Primary completion | 26 July 2021 |
| Estimated completion | 26 July 2021 |
| Sites | 1 location across United States |
Aaron Boes
Adults 18 to 80, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Global Improvement Scale (0-7 scale where 0=not assessed, 1=Very much improved, and 7= Very much worse
| Group | Value | 95% CI |
|---|---|---|
| TMS Treatment (Open Label, N = 1) | 4 |
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.
No peer-reviewed publications indexed yet for this trial.
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