NCT07267455 Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical Trial
| NCT ID | NCT07267455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Chronic Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 116 participants in total. It began in 2025-08-01 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety of personalized-target transcranial magnetic stimulation (TMS) in the treatment of chronic subjective tinnitus. The study aims to determine whether stimulation at individualized auditory cortex targets, identified by resting-state functional MRI, provides greater therapeutic benefit compared with conventional TMS targets. A total of 116 patients with chronic tinnitus will be recruited and randomly assigned to receive either personalized-target TMS or traditional-target TMS for five consecutive days. The main questions this study aims to answer are: Does personalized-target TMS improve tinnitus-related symptoms more effectively than traditional-target TMS? Is personalized-target TMS a safe and tolerable intervention for patients with chronic tinnitus? Researchers will compare the changes in tinnitus-related clinical rating scales between the two groups, including the Tinnitus Handicap Inventory (THI), Visual Analog Scale (VAS), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Participants will: Receive continuous theta burst stimulation (cTBS) targeting the left auditory cortex region showing the strongest functional connectivity with the parahippocampal gyrus, identified through resting-state fMRI. Undergo three cTBS sessions per day (600 pulses per session, 1,800 pulses total daily) for five days. Complete follow-up assessments at 1 month and 3 months after treatment to evaluate the durability of clinical effects. This study will also assess treatment adherence, safety outcomes, and potential predictors of therapeutic response to personalized-target TMS.
Eligibility 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.
Contact & Investigator
Yuexin Cai, Doctor
STUDY CHAIR
Yuexin Cai, Doctor
Frequently Asked Questions
Who can join the NCT07267455 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07267455 currently recruiting?
Yes, NCT07267455 is actively recruiting participants. Contact the research team at caiyx25@mail.sysu.edu.cn for enrollment information.
Where is the NCT07267455 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07267455 clinical trial?
NCT07267455 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Yuexin Cai, Doctor at Yuexin Cai, Doctor. The trial plans to enroll 116 participants.