Neck nerve electrical stimulation combined with sound-frequency training for chronic tonal tinnitus
Non-Invasively Re-Training the Tinnitus Brain Using Bimodal Electrical-Sound Stimulation (NITESGON-ADT): Protocol for a Prospective, Double-Blind, Randomised Controlled Trial
This trial tests whether pairing a safe electrical stimulation of the greater occipital nerve with an active sound-frequency training task can reduce tinnitus loudness and distress in adults with chronic tonal tinnitus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Dublin, Trinity College Academic / other |
| Locations | 1 site (Dublin, Dublin) |
| Trial ID | NCT07393880 on ClinicalTrials.gov |
What this trial studies
This single-centre, double-blind, placebo-controlled randomized trial at Trinity College Dublin will enrol 100 adults with chronic tonal tinnitus and randomize them equally into four groups in a 2×2 factorial design: real versus sham greater occipital nerve stimulation (NITESGON) and active versus passive listening. Participants complete eight in-person sessions over four weeks and are assessed at baseline, end of treatment, 28 days, and six months. Primary outcomes are tinnitus loudness (VAS), tinnitus functional impact (TFI), and tinnitus handicap (THI), with secondary measures including tinnitus psychoacoustics, extended high-frequency audiometry, speech-in-noise, EEG, autonomic/biomarker measures, quality of life, and safety/blinding. The study compares whether combining real nerve stimulation with attentionally demanding frequency discrimination training produces greater and longer-lasting benefit than sham stimulation or passive listening.
Who should consider this trial
Good fit: Adults aged 18–80 with continuous subjective predominantly tonal tinnitus lasting more than 3 months and up to 5 years, with THI 28–76 and MML 20–80 dB HL, no prior tinnitus neuromodulation, and ability to attend eight sessions and follow-ups are ideal candidates.
Not a fit: People with objective, pulsatile, predominantly somatic tinnitus, significant conductive or severe sensorineural hearing loss outside the study thresholds, active implantable medical devices, recent hearing-aid changes, severe psychiatric or cognitive impairment, or other excluded conditions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a non-invasive therapy that reduces tinnitus loudness and distress and improves daily functioning for people with chronic tonal tinnitus.
How similar studies have performed: Related bimodal approaches pairing peripheral nerve stimulation with sound-based training have shown promising but mixed early results, making this specific NITESGON plus active-listening combination relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18-80 years * Continuous subjective tinnitus for \>3 months and ≤5 years * Predominantly tonal tinnitus (unilateral or bilateral) * Screening THI score 28-76 * Minimum Masking Level (MML) 20-80 dB HL * No prior tinnitus neuromodulation treatment * Able to comply with eight sessions over four weeks and follow-up assessments Exclusion Criteria: * Objective tinnitus or predominantly somatic tinnitus * Pulsatile tinnitus * Evidence of conductive hearing loss (abnormal otoscopy or tympanometry) * Pure-tone audiometry exclusions: \>40 dB HL at any frequency 250 Hz-1 kHz OR \>80 dB HL at any frequency 2-8 kHz in either ear * Hearing aid use initiated within the past 90 days * Active implantable medical device (e.g., pacemaker, DBS, cochlear implant) * LDL \<30 dB SL at 500 Hz in either ear * Diagnosis of temporomandibular joint disorder or occipital neuralgia * Severe anxiety (STAI \>120/160) * Cognitive impairment (MMSE \<25) * Severe depressive symptoms (BDI ≥30) * Diagnosis of Menière's disease * Current pregnancy * Involvement in medicolegal cases * History of auditory hallucinations * Current prescription of central nervous system drugs likely to alter neuromodulatory function (e.g., noradrenergic, dopaminergic, serotonergic, benzodiazepine, cholinergic, or other psychoactive medications) * Currently enrolled in another interventional study
Where this trial is running
Dublin, Dublin
- Trinity College Institute of Neuroscience (TCIN) — Dublin, Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Sven Vanneste, PhD
- Email: sven.vanneste@tcd.ie
- Phone: +353 87 470 2835.
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.