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Efficacy and Safety of Transcranial Magnetic Stimulation in Patients with Chronic Subjective Tinnitus and Affective Symptoms

Efficacy and Safety of Transcranial Magnetic Stimulation in Patients with Chronic Subjective Tinnitus and Affective Symptoms: A Randomized, Double-Blind, Sham-Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129805
Enrollment
Unknown
Registered
2026-08-10
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjective tinnitus

Interventions

Control group:Sham repetitive transcranial magnetic stimulation

Sponsors

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age >= 18 years; 2) No gender restrictions; 3) Subjective tinnitus (a "sound experience perceived by the patient without an external sound source," which cannot be directly heard or recorded by others) lasting >= 6 months, with a THI score >= 38; 4) Concurrent anxiety symptoms with a HAMA score of =15, or concurrent depressive symptoms with a HAMD-17 score of >=8; 5) Able to cooperate with scale assessments, acoustic matching tests, and EEG recording; 6) The participant and legal guardian are willing to cooperate with treatment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Unilateral or bilateral hearing loss >= 60 dB 2) Presence of an organic cause that explains tinnitus symptoms, such as chronic otitis media, conductive hearing loss, sudden hearing loss, active Meniere’s disease, or pulsatile tinnitus; 3) Significant suicidal ideation (Item 3 of the HAMD-17 scale >= 2 points); 4) Risk of seizures or a family history of epilepsy; 5) Contraindications for transcranial magnetic stimulation or MRI, such as the presence of metal or electronic devices in the body (e.g., intracranial metal foreign bodies, cochlear implants, pacemakers, stents, or other metallic foreign bodies); 6) Severe central nervous system disorders, such as brain tumors/space-occupying lesions, stroke, severe traumatic brain injury, neurodegenerative diseases, or a history of brain surgery; 7) Other uncontrolled systemic diseases, such as severe cardiac, pulmonary, hepatic, or renal insufficiency, or uncontrolled thyroid disorders; 8) Pregnant or breastfeeding women, or women of childbearing age with a positive urine pregnancy test; 9) Individuals who have received targeted treatment for tinnitus within the past 4 weeks, such as psychotherapy, acoustic tinnitus masking devices, or hearing aids; 10) Individuals who have undergone TMS or other neurostimulation therapies within the past 6 months, or who have participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
THI score;

Secondary

MeasureTime frame
Scales for Measuring Emotions and Sleep-Related Factors;THI ;Psychoacoustic Assessment;Neurophysiological Outcomes;Safety Assessment;

Countries

China

Contacts

Public ContactZhang Zhili

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

zhangzhili@zju.edu.cn+86 571 88888888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026