Actively Recruiting
Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical Trial
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-12-05
116
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of personalized-target transcranial magnetic stimulation (TMS) for treating chronic subjective tinnitus. The study compares stimulation directed at individualized auditory cortex targets identified by resting-state functional MRI with conventional TMS targeting. The goal is to find out whether personalized targeting provides better relief from tinnitus symptoms and is well-tolerated by patients. This clinical trial is randomized and single-blind, involving 116 participants with chronic tinnitus. Participants will be randomly assigned to one of two groups. One group receives continuous theta burst stimulation (cTBS) aimed at the auditory cortex region with the strongest connection to the parahippocampal gyrus, pinpointed by resting-state fMRI. The other group receives cTBS at a standard auditory cortex site (CP5) used in previous tinnitus studies. Each participant undergoes three sessions daily, with 600 pulses per session, totaling 1,800 pulses per day, for five consecutive days. During the trial, participants will complete several assessments, including tinnitus severity, anxiety, depression, and sleep quality, measured at baseline, after treatment, and at 1- and 3-month follow-ups. Researchers will also monitor brain activity changes using EEG and MRI scans. The primary outcome is the rate of tinnitus relief five days after treatment. Safety, adherence, and factors predicting response to personalized TMS will also be evaluated. Total participation spans from enrollment through the 3-month follow-up period.
CONDITIONS
Brief Title
Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with subjective tinnitus as the main complaint, perceiving sounds without external stimulation
- Chronic tinnitus lasting more than 6 months with a Tinnitus Handicap Inventory score of 38 or higher
- No response to conventional drug treatments for tinnitus
- Outpatients able to undergo continuous 5-day continuous theta burst stimulation (cTBS) treatment at the study hospital
- Tinnitus frequency between 125 Hz and 8000 Hz
- Age between 18 and 70 years
You will not qualify if you...
- Tinnitus caused by conductive hearing loss, history of middle ear surgery, pulsatile tinnitus from vascular malformations, or Meniere's disease
- History of head trauma, central nervous system diseases, psychiatric disorders, or substance abuse
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 consecutive days
Participants receive continuous theta burst stimulation (cTBS) applied to the left auditory cortex. Stimulation is either personalized-target based on resting-state fMRI or at the conventional CP5 site. Each session consists of 600 pulses, delivered three times daily for five consecutive days.
Daily visits for 5 days with three sessions per day
Duration - 3 months
Participants are monitored for tinnitus relief and related symptoms including tinnitus loudness, anxiety, depression, sleep quality, and EEG/MRI changes after treatment.
Visits at 1 month and 3 months post-treatment
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
Y
Yuexin Cai, Doctor
Q
Qianhui Xu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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