Non-Invasively Re-Training the Tinnitus Brain Using Bimodal Electrical-Sound Stimulation (NITESGON-ADT): Protocol for a Prospective, Double-Blind, Randomised Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Ireland
Trinity College Institute of Neuroscience (TCIN)
RECRUITING
Dublin
Contact Information
Primary
Sven Vanneste, PhD
sven.vanneste@tcd.ie
+35318968521
Backup
Anusha Mohan, PhD
anusha.mohan@tcd.ie
Time Frame
Start Date:2026-01-30
Estimated Completion Date:2029-01-30
Participants
Target number of participants:100
Treatments
Experimental: Real Stimulation + Active Listening (ADT)
Real stimulation delivered during active auditory frequency discrimination training.
Active_comparator: Real Stimulation + Passive Listening
Real stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli.
Sham_comparator: Sham Stimulation + Active Listening (ADT)
Sham stimulation delivered during active auditory frequency discrimination training.