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NCT Number: NCT07267455

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

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.

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Key information

Conditions

Chronic Tinnitus

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

CONTACT

[email protected]

13719908396

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Theta Burst Stimulation

Device

This study evaluates personalized-target and conventional-target transcranial magnetic stimulation (TMS) for the treatment of chronic subjective tinnitus. Participants will receive continuous theta burst stimulation (cTBS) applied to the left auditory cortex. For the personalized-target arm, stimulation sites are individualized based on resting-state fMRI, targeting the region of strongest functional connectivity with the parahippocampal gyrus. For the conventional-target arm, stimulation is delivered at the CP5 site. Each session consists of 600 pulses, delivered in three sessions per day (1,800 pulses daily) for five consecutive days.

Primary outcomes

  1. the effective rate of chronic tinnitus relief in the two groups of patients before treatment and 5 days after treatment

    Time frame: From enrollment to the end of treatment at 5 days

    It is defined as follows:

    Effective rate = [(Number of patients in each group who completed the 5-day treatment and had a Tinnitus Handicap Inventory (THI) score decrease of ≥ 7 points from the baseline) / (Total number of patients in each group who completed the 5-day treatment)] × 100%. The assessment time points for this outcome are before treatment (baseline) and 5 days after treatment.

Secondary outcomes

  1. Tinnitus Loudness

    Time frame: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up

    Change in tinnitus loudness, assessed using the Visual Analog Scale (VAS), which ranges from 0 (no tinnitus) to 10 (worst tinnitus imaginable).

  2. Anxiety Symptoms

    Time frame: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up

    Change in anxiety symptoms, assessed using the Beck Anxiety Inventory (BAI), a self-reported questionnaire measuring severity of anxiety.

  3. Depressive Symptoms

    Time frame: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up

    Change in depressive symptoms, assessed using the Beck Depression Inventory (BDI), a self-reported scale evaluating severity of depression.

  4. Sleep Quality

    Time frame: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up

    Change in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep quality and disturbances over a 1-month period.

  5. Long-term Efficacy of Tinnitus Relief

    Time frame: 1-month follow-up, 3-month follow-up

    Effective rate = [(Number of patients in each group who completed the 5-day treatment and had a Tinnitus Handicap Inventory (THI) score decrease of ≥ 7 points from the baseline) / (Total number of patients in each group who completed the 5-day treatment)] × 100%. The assessment time points for this outcome are before treatment (baseline) and 1 month, 3 month after treatment.

  6. EEG Changes

    Time frame: Baseline (pre-treatment), post-treatment (day 5), 1-month follow-up, 3-month follow-up

    Changes in electroencephalography (EEG) measures associated with tinnitus and cortical activity, assessed before treatment, after 5 days of intervention, and at 1-month and 3-month follow-ups.

  7. MRI Changes

    Time frame: Baseline (pre-treatment), 1-month follow-up

    Changes in brain structure and functional connectivity assessed using magnetic resonance imaging (MRI), including the auditory cortex and related networks. MRI is performed at baseline (pre-treatment) and at 1-month follow-up to evaluate early post-treatment neural changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Qianhui Xu, MD

CONTACT

[email protected]

86+13719908396

Yuexin Cai, Doctor

CONTACT

[email protected]

86+13825063663

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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