Personalized-target transcranial magnetic stimulation for chronic tinnitus
Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical Trial
This trial will test whether TMS aimed at each person's auditory cortex using their resting-state MRI helps adults with chronic tinnitus more than standard TMS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07267455 on ClinicalTrials.gov |
What this trial studies
This single-center, single-blind randomized trial will enroll 116 adults with chronic subjective tinnitus and randomly assign them to personalized-target TMS or conventional-target TMS. Personalized targets are identified using resting-state functional MRI to localize auditory cortex regions, and both groups receive continuous theta burst stimulation delivered over five consecutive days. Researchers will compare changes in tinnitus clinical rating scales, including the Tinnitus Handicap Inventory, between the two groups to measure symptom change and tolerability. Safety and adverse events will be monitored to determine whether individualized targeting provides greater therapeutic benefit than standard targeting.
Who should consider this trial
Good fit: Adults aged 18–70 with chronic subjective tinnitus lasting more than 6 months, a THI score ≥38, tinnitus frequency between 125 Hz and 8000 Hz, no response to conventional drug treatment, and who can attend five consecutive outpatient cTBS sessions at the site are appropriate candidates.
Not a fit: Patients with tinnitus due to conductive hearing loss, middle ear surgery, pulsatile (vascular) tinnitus, Meniere's disease, or with a history of head trauma, central nervous system disease, psychiatric disorders, substance abuse, or who are pregnant are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, personalized-target TMS could reduce tinnitus severity more than standard TMS and improve daily functioning for some patients.
How similar studies have performed: Previous TMS studies for tinnitus have shown mixed but sometimes modest benefits, and fMRI-guided personalized targeting is a relatively novel approach with preliminary promising signals but not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Patients with tinnitus as the main complaint: Patients perceive subjective sounds in the ears or deep within the skull in the absence of internal or external acoustic stimulation. 2.Patients with chronic tinnitus who meet the conditions including tinnitus duration of more than 6 months, THI (tinnitus handicap inventory) score ≥ 38, and no response to conventional drug treatment. 3.Outpatients of Sun Yat-sen University Sun Yat-sen Memorial Hospital who can receive continuous 5-day cTBS treatment. 4.Tinnitus frequency ranges from 125 Hz to 8000 Hz. 5.Aged 18-70 years. Exclusion Criteria: * 1.Patients with tinnitus associated with the following conditions: conductive hearing loss, a history of middle ear surgery, pulsatile tinnitus caused by vascular malformations, or Meniere's disease. 2.A history of any of the following: head trauma, central nervous system diseases, psychiatric disorders, or substance abuse. 3.Pregnancy.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yuexin Cai, Doctor
- Email: caiyx25@mail.sysu.edu.cn
- Phone: 86+13825063663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.