Neck nerve electrical stimulation combined with sound-frequency training for chronic tonal tinnitus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Non-Invasive Neurofeedback for Tinnitus Distress

  This trial tests whether real-time neurofeedback training can reduce distress from tinnitus in adults with bothersome symptoms.

  Recruiting University of Illinois at Urbana-Champaign · Urbana, Illinois · NCT07788638

• Noninvasive ear cooling for tinnitus

  This trial will try a noninvasive mild ear cooling device called ReBound to see if a single 30-minute session plus up to six months of home use reduces chronic subjective tinnitus in adults.

  Recruiting Restorear Devices LLC · Miami, Florida · NCT07071480

• External mild-cooling therapy for chronic tinnitus

  This test will see if wearing a mild external cooling device for 30 minutes can reduce symptoms in adults 18–55 with constant subjective tinnitus.

  Recruiting Restorear Devices LLC · Bozeman, Montana · NCT07017998

• DeepTMS for chronic tinnitus using different H-coils

  This study tests whether deep repetitive transcranial magnetic stimulation with different H-coils can reduce tinnitus distress in adults with chronic tinnitus, compared to placebo.

  Recruiting University of Regensburg · Regensburg, Bavaria · NCT07885176

• TRTL-913 in adults with tinnitus: safety and signals of benefit

  This trial tests TRTL-913 versus placebo in healthy adults and in adults with tinnitus to see if it is safe, tolerable, and potentially helpful for tinnitus patients.

  Recruiting Phase 2 Tortugas Neuroscience, Inc. · Newcastle, New South Wales and 9 other locations · NCT07777549

• Foot reflexology or ta-VNS for tinnitus in adults

  This trial tests whether foot reflexology, left-ear vagus nerve stimulation, or auricular acupressure can help reduce tinnitus symptoms in adults with tinnitus.

  Recruiting Tzu Chi University · Hualien City · NCT07711639

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.