Chronic TinnitusNCT07267455
Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical Trial
A study testing continuous theta burst stimulation in people with Chronic Tinnitus, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Tinnitus
- What is being tested?
- continuous theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
13719908396, xuqh9@mail2.sysu.edu.cn
About this study
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.
Read more
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
- Chronic Tinnitus
- Being tested
- continuous theta burst stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous theta burst stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized-Target TMS Group | Experimental | 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. Receives: Device: continuous theta burst stimulation |
| conventional auditory cortex site | Active comparator | 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). Receives: Device: continuous theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effective rate of chronic tinnitus relief in the two groups of patients before treatment and 5 days after treatment
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.
Measured: From enrollment to the end of treatment at 5 days
Secondary outcomes (7)
Tinnitus Loudness
Change in tinnitus loudness, assessed using the Visual Analog Scale (VAS), which ranges from 0 (no tinnitus) to 10 (worst tinnitus imaginable).
Measured: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up
Anxiety Symptoms
Change in anxiety symptoms, assessed using the Beck Anxiety Inventory (BAI), a self-reported questionnaire measuring severity of anxiety.
Measured: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up
Depressive Symptoms
Change in depressive symptoms, assessed using the Beck Depression Inventory (BDI), a self-reported scale evaluating severity of depression.
Measured: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up
Sleep Quality
Change in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep quality and disturbances over a 1-month period.
Measured: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up
Long-term Efficacy of Tinnitus Relief
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.
Measured: 1-month follow-up, 3-month follow-up
EEG Changes
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.
Measured: Baseline (pre-treatment), post-treatment (day 5), 1-month follow-up, 3-month follow-up
MRI Changes
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.
Measured: Baseline (pre-treatment), 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Aug 2025
- Primary completionJan 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic TinnitusStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuexin Cai, Doctor, Study chair, Yuexin Cai, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267455
- Sponsor's protocol ID
- SYSKY-2025-648-02
- Status last verified
- Oct 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared due to privacy concerns and ethical restrictions related to patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07267455
- Acronym / sponsor ID
- SYSKY-2025-648-02
- Conditions
- Chronic Tinnitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized-Target TMS Group | Experimental | Device: continuous theta burst stimulationParticipants 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. |
| conventional auditory cortex site | Active comparator | Device: continuous theta burst stimulationParticipants 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous theta burst stimulationThis 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. | Device | Personalized-Target TMS Group, conventional auditory cortex site |
Primary outcome
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.
7 secondary outcomes
Tinnitus Loudness
Time frame: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up
Anxiety Symptoms
Time frame: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up
Depressive Symptoms
Time frame: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up
Sleep Quality
Time frame: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up
Long-term Efficacy of Tinnitus Relief
Time frame: 1-month follow-up, 3-month follow-up
EEG Changes
Time frame: Baseline (pre-treatment), post-treatment (day 5), 1-month follow-up, 3-month follow-up
MRI Changes
Time frame: Baseline (pre-treatment), 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared due to privacy concerns and ethical restrictions related to patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuexin Cai, Doctor study chair
Yuexin Cai, Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous theta burst stimulation in people with Chronic Tinnitus, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuexin Cai, Doctor (86+13825063663, caiyx25@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.