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

NCT07393880 | Recruiting DMC

• 2 other identifiers: NITESGON-SPREC102020-46DRG2332
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus, Subjective; Tinnitus; Chronic Tinnitus

Keywords

Tinnitus

Outcome Measures

Primary Outcomes (3)

• Tinnitus Loudness (Visual Analogue Scale, VAS 0-100)

  0-100 mm VAS anchored from "not audible" to "extremely loud"; higher scores indicate greater perceived tinnitus loudness.

  Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

• Tinnitus Functional Index (TFI, 0-100)

  25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.

  Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

• Tinnitus Handicap Inventory (THI, 0-100)

  25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap.

  Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

Secondary Outcomes (15)

• Audiometry (Extended High-Frequency Thresholds up to 13 kHz)

  Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

• Speech-in-Noise Performance (e.g., QuickSIN)

  Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

• Patient Global Impression of Change (PGIC)

  End of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

• Quality of Life (World Health Organization Quality of Life-BREF questionnaire)

  Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

• Adverse Events (Stimulation Side-Effects Questionnaire)

  Up to 4 weeks (Sessions 1-8)

Study Arms (4)

Real Stimulation + Active Listening (ADT)

EXPERIMENTAL

Real stimulation delivered during active auditory frequency discrimination training.

Device: Real NITESGON; Behavioral: Active Listening

Real Stimulation + Passive Listening

ACTIVE COMPARATOR

Real stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli.

Device: Real NITESGON; Behavioral: Passive Listening (Control)

Sham Stimulation + Active Listening (ADT)

SHAM COMPARATOR

Sham stimulation delivered during active auditory frequency discrimination training.

Device: Sham NITESGON; Behavioral: Active Listening

Sham Stimulation + Passive Listening

SHAM COMPARATOR

Sham stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli.

Device: Sham NITESGON; Behavioral: Passive Listening (Control)

Interventions

Real NITESGON DEVICE

Real NITESGON is delivered transcutaneously via two saline-soaked sponge electrodes (35 cm² each) positioned bilaterally over the C2 dermatomes to target the greater occipital nerve. Stimulation consists of a 20 Hz sinusoidal current at 1.5 mA peak-to-peak, ramped up over 30 seconds and ramped down over 5 seconds. It is administered concurrently with the task for \~45 minutes per session, across eight sessions (2/week) over 4 weeks.

Real Stimulation + Active Listening (ADT); Real Stimulation + Passive Listening

Sham NITESGON DEVICE

Sham NITESGON is delivered using two saline-soaked sponge electrodes (35 cm² each) positioned bilaterally over the C2 dermatomes. The sham condition mimics real stimulation sensations via a 30-second ramp-up followed by a brief ramp-down, with no sustained current thereafter. Sham is administered concurrently with the task for \~45 minutes per session, across eight sessions (2/week) over 4 weeks.

Sham Stimulation + Active Listening (ADT); Sham Stimulation + Passive Listening

Active Listening BEHAVIORAL

ADT is delivered using a three-interval, three-alternative forced-choice (3I-3AFC) frequency discrimination task. Standard tone frequencies are individually selected using ERB/critical-band spacing, centered one octave below each participant's dominant tinnitus pitch and extending to lower frequencies; the highest standard is kept below the tinnitus pitch region. Tones are presented binaurally via headphones, with presentation levels calibrated to individual audiometric thresholds and matched for equal SPL in both ears.

Also known as: Auditory frequency discrimination training (ADT)

Real Stimulation + Active Listening (ADT); Sham Stimulation + Active Listening (ADT)

Passive Listening (Control) BEHAVIORAL

VisDT uses a three-interval, three-alternative forced-choice (3I-3AFC) paradigm with Gabor patches (sinusoidal gratings windowed by a Gaussian envelope) of fixed spatial frequency (6 cycles/degree) and fixed spatial spread; on each trial, one interval contains an orientation deviant relative to the standard. During VisDT, participants attend to the visual task while concurrent binaural tones are presented passively using a predetermined, non-adaptive schedule. Auditory tones are individually calibrated to audiometric thresholds and drawn from ERB-spaced frequencies centered one octave below the dominant tinnitus pitch and extending to lower frequencies, with the highest frequency kept below the tinnitus pitch region.

Also known as: Visual distractor task (VisDT)

Real Stimulation + Passive Listening; Sham Stimulation + Passive Listening

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Objective tinnitus or predominantly somatic tinnitus
• Pulsatile tinnitus
• Evidence of conductive hearing loss (abnormal otoscopy or tympanometry)
• 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)

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

Trinity College Institute of Neuroscience (TCIN)

Dublin, Dublin, D02, Ireland

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sven Vanneste, PhD

CONTACT

+35318968521; sven.vanneste@tcd.ie

Anusha Mohan, PhD

CONTACT

anusha.mohan@tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to stimulation condition (real vs sham NITESGON). Outcome assessors and data analysts are blinded to group allocation. The investigator operating the stimulation device does not take part in outcome assessments and follows coded procedures to deliver real or sham stimulation.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2×2 factorial randomised controlled trial with two between-subjects factors: stimulation condition (real vs sham NITESGON) and listening condition (active auditory discrimination training vs passive listening during a visual task). Participants are assigned 1:1:1:1 to four parallel arms.

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 6, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

IE (1)