Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07267455

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

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with tinnitus as the main complaint, experiencing subjective sounds without external acoustic stimulation
  • Chronic tinnitus lasting more than 6 months
  • Tinnitus Handicap Inventory (THI) score of 38 or higher
  • No response to conventional drug treatment for tinnitus
  • Outpatients able to receive continuous 5-day continuous theta burst stimulation (cTBS) treatment
  • Tinnitus frequency between 125 Hz and 8000 Hz
  • Aged between 18 and 70 years
Not Eligible

You will not qualify if you...

  • Tinnitus related to 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

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

Y

Yuexin Cai, Doctor

CONTACT

Q

Qianhui Xu, MD

CONTACT

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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