Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

⁃ 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.

⁃ Outpatients of Sun Yat-sen University Sun Yat-sen Memorial Hospital who can receive continuous 5-day cTBS treatment.

⁃ Tinnitus frequency ranges from 125 Hz to 8000 Hz. 5.Aged 18-70 years.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Yuexin Cai, Doctor
caiyx25@mail.sysu.edu.cn
86+13825063663
Backup
Qianhui Xu, MD
xuqh9@mail2.sysu.edu.cn
86+13719908396
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2030-08
Participants
Target number of participants: 116
Treatments
Experimental: Personalized-Target TMS Group
Participants receive continuous theta burst stimulation (cTBS) targeting the individualized auditory cortex region showing the strongest functional connectivity with the left parahippocampal gyrus, as identified by resting-state fMRI. Each participant receives 600 pulses per session, 3 sessions per day (total 1,800 pulses daily) for 5 consecutive days.
Active_comparator: conventional auditory cortex site
Participants receive continuous theta burst stimulation (cTBS) targeting the left auditory cortex at EEG 10-20 system site CP5, as used in prior tinnitus studies. Stimulation parameters are identical to the experimental group (600 pulses per session, 3 sessions per day, for 5 consecutive days).
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov