ArticleNeuromodulation : journal of the International Neuromodulation Society2016
An Investigation of Feasibility and Safety of Bi-Modal Stimulation for the Treatment of Tinnitus: An Open-Label Pilot Study.
Article in Neuromodulation : journal of the International Neuromodulation Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Guideline
- Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial.Scientific reports · 2022Trial
- Trial
- Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial.Nature communications · 2024Article
- Effects of Non-Invasive Neuromodulation of the Vagus Nerve for Management of Tinnitus: A Systematic Review with Meta-Analysis.Journal of clinical medicine · 2023Review
- A State-of-Art Review of Digital Technologies for the Next Generation of Tinnitus Therapeutics.Frontiers in digital health · 2021Review
- Bimodal Auditory Electrical Stimulation for the Treatment of Tinnitus: Preclinical and Clinical Studies.Current topics in behavioral neurosciences · 2021Article
- Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters.JMIR research protocols · 2019Article
- A Pilot Study of Peripheral Muscle Magnetic Stimulation as Add-on Treatment to Repetitive Transcranial Magnetic Stimulation in Chronic Tinnitus.Frontiers in neuroscience · 2018Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTinnitus is the perception of sound in the absence of an external auditory stimulus. It is widely believed that tinnitus, in patients with associated hearing loss, is a neurological phenomenon primarily affecting the central auditory structures. However, there is growing evidence for the involvement of the somatosensory system in this form of tinnitus. For this reason it has been suggested that the condition may be amenable to bi-modal stimulation of the auditory and somatosensory systems. We conducted a pilot study to investigate the feasibility and safety of a device that delivers simultaneous auditory and somatosensory stimulation to treat the symptoms of chronic tinnitus.
methodsA cohort of 54 patients used the stimulation device for 10 weeks. Auditory stimulation was delivered via headphones and somatosensory stimulation was delivered via electrical stimulation of the tongue. Patient usage, logged by the device, was used to classify patients as compliant or noncompliant. Safety was assessed by reported adverse events and changes in tinnitus outcome measures. Response to treatment was assessed using tinnitus outcome measures: Minimum Masking Level (MML), Tinnitus Loudness Matching (TLM), and Tinnitus Handicap Inventory (THI).
resultsThe device was well tolerated by patients and no adverse events or serious difficulties using the device were reported. Overall, 68% of patients met the defined compliance threshold. Compliant patients (N = 30) demonstrated statistically significant improvements in mean outcome measures after 10 weeks of treatment: THI (-11.7 pts, p < 0.001), TLM (-7.5dB, p < 0.001), and MML (-9.7dB, p < 0.001). The noncompliant group (N = 14) demonstrated no statistical improvements.
conclusionThis study demonstrates the feasibility and safety of a new bi-modal stimulation device and supports the potential efficacy of this new treatment for tinnitus.
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