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Stimulating tinnitus research
Neuromod Devices is dedicated to validating its breakthrough tinnitus treatment approach in large randomized clinical trials in tinnitus patients. Neuromod Devices is an innovative company formed in late 2010 to clinically investigate ground-breaking tinnitus treatment technology that originated in the National University of Ireland, Maynooth.
To test and confirm the scientific hypothesis underlying this ground-breaking approach, Neuromod has embarked on a unprecedentedly robust clinical programme:
Tinnitus is a complex neurological condition that involves hearing, attention and emotion centers in the brain. Unlike sound therapies and noise maskers that only deliver one type of stimulus to the brain (sound), Neuromod’s approach combines auditory stimulation (sound) with trigeminal nerve stimulation, which is achieved noninvasively as gentle energy pulses delivered to the surface of the tongue by a proprietary tonguetip® device. By combining these neuromodulatory stimuli, Neuromod believes that greater and more sustained efficacy may be achieved.
2012: TAVSS single arm trial in 60 patients²
Visit www.neuromoddevices.com for more information
2010: Proof of principle in 20 patients¹ 2016: Randomized double-blind multi-arm trial in 326 patients with 12 month long-term post-treatment follow up (TENT-A1)³ 2018: Randomized double-blind multi-arm confirmatory trial in 191 patients with 12 month long-term post-treatment follow up (TENT-A2)⁴ Neuromod will share the results of the TENT trials once complete and will work with regulatory authorities to make the product available to patients as soon as possible.
For further reference: 1.
WO2012069429A1; Method and apparatus for sensory substitution; Paul O’grady. Ross O’Neill, Barak A. Pearlmutter
2.
Hamilton, Caroline, et al. “An Investigation of Feasibility and Safety of Bi-Modal Stimulation for the Treatment of Tinnitus: An Open-Label Pilot Study.” Neuromodulation: Technology at the Neural Interface 19.8 (2016): 832-837.; ClinicalTrials.gov Identifier: NCT02570048
3.
D’Arcy, Shona, et al. “Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping.” BMJ open 7.10 (2017): e018465.; ClinicalTrials.gov Identifier: NCT02669069
4.
ClinicalTrials.gov Identifier: NCT03530306Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)
