Non-Invasively Re-Training the Tinnitus Brain Using Bimodal Electrical-Sound Stimulation (NITESGON-ADT): Protocol for a Prospective, Double-Blind, Randomised Controlled Trial

What this Trial Is About

Researchers are evaluating a new approach to reduce tinnitus loudness and distress in adults with chronic tonal tinnitus. The study tests non-invasive electrical stimulation of the greater occipital nerve (NITESGON) combined with an attention-demanding auditory frequency discrimination training task. Conducted as a double-blind, placebo-controlled trial at Trinity College Dublin, the study involves 100 adults randomized into four groups to compare real versus sham stimulation and active versus passive listening. Participants receive eight sessions over four weeks, with two sessions each week. The interventions include real or sham NITESGON delivered via electrodes on the neck while participants either actively engage in auditory training or passively listen during a visual task. Each session lasts about 45 minutes. The study measures tinnitus loudness, functional impact, and handicap, among other auditory and physiological outcomes. Throughout the study, participants undergo assessments at baseline, after treatment, and at 28 days and 6 months post-treatment. Evaluations include tinnitus loudness scales, questionnaires, hearing tests, speech-in-noise performance, EEG recordings, heart rate, saliva biomarkers, and quality of life measures. Safety and blinding are monitored during the treatment period. The total participation spans several months with follow-up visits to track long-term effects.

Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus