Actively Recruiting
Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus
Led by University of Dublin, Trinity College · Updated on 2026-04-03
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study tests whether pairing non-invasive stimulation of the greater occipital nerve (NITESGON) with an attentionally demanding auditory frequency discrimination training task reduces tinnitus loudness and tinnitus-related distress. One hundred adults with chronic tonal tinnitus will be randomised to one of four groups in a 2×2 factorial design: real versus sham NITESGON and active versus passive listening during auditory stimulation. Participants complete eight sessions across four weeks, with outcomes assessed at baseline, end of treatment, 28 days post-treatment, and 6 months post-treatment.
CONDITIONS
Official Title
Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-80 years
- Continuous subjective tinnitus lasting more than 3 months and up to 5 years
- Predominantly tonal tinnitus in one or both ears
- Screening Tinnitus Handicap Inventory score between 28 and 76
- Minimum Masking Level between 20 and 80 dB HL
- No prior neuromodulation treatment for tinnitus
- Ability to attend eight sessions over four weeks and complete follow-up assessments
You will not qualify if you...
- Objective or predominantly somatic tinnitus
- Pulsatile tinnitus
- Conductive hearing loss shown by abnormal ear examination or tympanometry
- Hearing loss greater than 40 dB HL at any frequency between 250 Hz and 1 kHz or greater than 80 dB HL at any frequency between 2 kHz and 8 kHz in either ear
- Hearing aid use started within the past 90 days
- Presence of active implantable medical devices such as pacemakers, deep brain stimulators, or cochlear implants
- Loudness Discomfort Level less than 30 dB SL at 500 Hz in either ear
- Diagnosis of temporomandibular joint disorder or occipital neuralgia
- Severe anxiety with State-Trait Anxiety Inventory score over 120
- Cognitive impairment with Mini-Mental State Examination score below 25
- Severe depressive symptoms with Beck Depression Inventory score of 30 or higher
- Diagnosis of Menière's disease
- Current pregnancy
- Involvement in medicolegal cases
- History of auditory hallucinations
- Current use of central nervous system drugs that affect neuromodulation
- Participation in another interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Trinity College Institute of Neuroscience (TCIN)
Dublin, Dublin, Ireland, D02
Actively Recruiting
Research Team
S
Sven Vanneste, PhD
CONTACT
A
Anusha Mohan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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