Neural and Clinical Effects of 40 Hz Burst Stimulation in Tinnitus: a Four-phase Self-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 265
- Locations
- 1
- Primary Endpoint
- Residual inhibition duration
Study Overview
Brief Summary
Tinnitus affects 10-15% of adults and is frequently associated with impaired quality of life, anxiety, and sleep disturbance. Conventional sound therapies based on continuous masking provide inconsistent and short-lived relief, and the neural mechanisms underlying residual inhibition (RI) remain unclear.
This study aims to determine whether 40 Hz burst stimulation with high-frequency carriers can achieve longer-lasting RI than continuous sound, and to explore its underlying neural mechanisms using EEG.
Detailed Description
Residual inhibition (RI) refers to the temporary reduction or disappearance of tinnitus following sound stimulation and provides an important clue for identifying patients who may benefit from acoustic therapy. However, the effects of different sound stimulation strategies on RI remain poorly understood.
This study evaluates whether 40 Hz burst-modulated sound achieves stronger and longer RI compared with conventional continuous stimulation. The trial follows a four-phase design:
Phase 1: Exploratory testing of burst versus continuous tones at different frequencies.
Phase 2: Large-scale validation in 265 patients. Phase 3: Development of a personalized stimulation protocol using adaptive spectral optimization.
Phase 4: EEG investigation of neural mechanisms, focusing on gamma oscillations and functional connectivity changes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with subjective tinnitus;
- •Chronic tinnitus: tinnitus course ≥ 1 month;
- •Normal middle ear function;
- •The average hearing threshold (defined as mean of 0.5, 1, 2, and 4 kHz) of the unaffected ear < 60 dB;
- •Tinnitus can be heard under normal circumstances.
- •Subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent.
Exclusion Criteria
- •Acute phase tinnitus;
- •Fluctuating tinnitus loudness;
- •Severe psychiatric disorders;
- •Inability to complete tinnitus testing;
- •Fluctuating or retrocochlear hearing loss;
- •Conductive hearing loss;
- •Currently participating in other research projects that may affect tinnitus;
- •Subjects who are not considered suitable for this clinical trial by the researchers.
Arms & Interventions
Personalized 40 Hz Broadband Stimulation
Participants receive personalized broadband acoustic stimulation modulated at 40 Hz. An adaptive equalization algorithm, based on individual and population residual inhibition (RI) responses, is used to weight frequency components across 125 Hz-12 kHz.
Intervention: Personalized 40 Hz Broadband Stimulation (Other)
40 Hz Pure Tone Stimulation
Participants receive pure tone stimulation at the individually optimized carrier frequency identified in earlier phases, amplitude-modulated at 40 Hz.
Intervention: 40 Hz Pure Tone Stimulation (Other)
Continuous Broadband Noise
Participants receive continuous broadband noise stimulation without 40 Hz modulation.
Intervention: Continuous Broadband Noise (Other)
Outcomes
Primary Outcomes
Residual inhibition duration
Time Frame: Immediately after the sound stimulation session.
Time in seconds until tinnitus returns to baseline after stimulation
Tinnitus suppression strength
Time Frame: Immediately after the sound stimulation session.
Residual inhibition depth, 0-100% reduction
Secondary Outcomes
- EEG spectral power changes(measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation))
- EEG functional connectivity changes(measured across the entire 10-minute EEG recording session (baseline, during stimulation, and post-stimulation))