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2026-10-09 00:00 Clinical Launch & Registration Source language EN

Registered Study Plans to Assess Tinnitus Using a Non-Invasive Brain-Computer Interface

Summary A registered observational case-control study plans to explore objective assessment of subjective tinnitus using non-invasive brain-computer interface technology. It aims to enroll 150 people with chronic tinnitus and 150 healthy controls. The primary outcome is auditory event-related potentials, brain electrical responses associated with sound events. Secondary measures include tinnitus handicap, anxiety and depression scale scores, pure-tone thresholds, noise exposure, and medication history. Controls will be matched to patients by age and other relevant characteristics, and neither group will receive an intervention. Recruitment is pending; the study does not yet establish diagnostic accuracy or treatment effects.
Why it matters The study concerns objective assessment rather than BCI-based tinnitus treatment. Its design records auditory brain responses alongside symptom scales, hearing measures, and exposure history; subsequent work will need to show how these measures contribute to validating an assessment method.

BCIwiki (bciwiki.com) — According to study registration information from Medical School of Tianjin University, a Chinese Clinical Trial Registry (ChiCTR) record reproduced by the WHO International Clinical Trials Registry Platform (WHO ICTRP) lists a study exploring objective assessment of subjective tinnitus using non-invasive brain-computer interface (BCI) technology. It was registered on 2026-10-09 as ChiCTR2600133938. Medical School of Tianjin University is the listed primary sponsor.

The observational case-control study plans to enroll 150 participants with chronic tinnitus and 150 healthy controls in China, with both sexes eligible. Patients must be aged 18 years or older, be able to complete the relevant hearing tests, and provide written informed consent. Healthy controls will be matched to patients for age and other relevant characteristics. The intervention field is None for both groups.

The primary outcome is auditory event-related potentials, brain electrical responses associated with sound events. Secondary outcomes include Tinnitus Handicap Inventory scores, Self-Rating Anxiety Scale scores, self-rating depression scale scores, pure-tone thresholds, noise exposure, and medication history. The study aims to explore objective assessment methods, not to test a tinnitus treatment.

The study was prospectively registered, with estimated first enrollment on 2026-10-15. The record was last updated on 12 October 2026 and lists recruitment as Pending. The estimated enrollment date does not establish that enrollment has actually begun. No results are available to determine the accuracy of the assessment method.

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