TinnitusNCT07435298
Navigated Repetitive TMS for Chronic Tinnitus
A study testing navigated rTMS in people with Tinnitus, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study is testing whether a special type of brain stimulation called neuronavigated TMS can help reduce tinnitus (ringing in the ears). 50 people with tinnitus will each receive 20 treatment sessions - 10 real treatments and 10 sham treatments in random order, with a 2-week break between them. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- navigated rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80 years old;
- Subjective tinnitus severity as per Tinnitus-Visual Analogue Scale of 1/10 and above (in any domain: sound, distress, Quality of Life)
Who cannot join
- Pregnancy;
- Any metal implants inside the body that are contraindications of MRI scan;
- Cardiac pacemakers;
- Epilepsy with recurrent seizures;
- Cognitively impaired patients will be excluded;
- Claustrophobia;
Show all 9Show fewer
- Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- Major depression and a history of psychotic disorders;
- Terminal diagnosis with life expectancy <=1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuronavigated Transcranial Magnetic Stimulation As An Adjunctive Treatment For Chronic Tinnitus
This study is testing whether a special type of brain stimulation called neuronavigated TMS can help reduce tinnitus (ringing in the ears). 50 people with tinnitus will each receive 20 treatment sessions - 10 real treatments and 10 sham treatments in random order, with a 2-week break between them. Before starting, participants get an MRI brain scan to guide where the stimulation device is placed. Questionnaires of measuring tinnitus severity will be asked four times throughout the study to determine to check the effect of TMS on treating tinnitus.
Read the detailed description
This study aims to investigate the beneficial effects of neuronavigated TMS (nTMS) in alleviating tinnitus symptoms and to establish safety and tolerability of nTMS in patients with tinnitus.
50 eligible subjects will be recruited and be randomized to receive 10 sessions of daily verum nTMS followed by 10 sessions of daily sham nTMS (verum-sham), or sham nTMS followed by verum nTMS (sham-verum). There will be a 2-week break between the two types of nTMS.
MRI will be conducted before the 1st session of nTMS for the TMS navigation system.
Outcome measures include Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus-Visual Analogue Scale (T-VAS). All assessment will be evaluated 4 times- before the 1st nTMS session, after the 10th nTMS session, before the 11th nTMS and after the 20th nTMS session.
- Conditions
- Tinnitus
- Being tested
- navigated rTMS
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated rTMSDevice
Each session of rTMS (real or sham) consists of 1200 stimulations/day, conducted at once a day for five consecutive days (from Monday to Friday).
For sham stimulation, the TMS coil will still centre on the same scalp position, but it was tilted to 90° so that scalp contact and discharging noise were similar, but the magnetic field did not reach cortical neurons at a biologically active level.
The localization of the rTMS stimulation site (left Temporal Cortex) will be directed by a neuronavigation system imported with subject's MRI scan imaging to ensure the accuracy of rTMS stimulation area.
| Study group | Role | What they receive |
|---|---|---|
| real-sham | Experimental | Subjects will receive 10 sessions of real nTMS, 5 times a week for 2 weeks, followed by 10 sessions of sham nTMS, 5 times a week for 2 weeks. There will be a 2-week break between the 2 types of nTMS. Receives: Device: navigated rTMS |
| sham-real | Experimental | Subjects will receive 10 sessions of sham nTMS, 5 times a week for 2 weeks, followed by 10 sessions of real nTMS, 5 times a week for 2 weeks. There will be a 2-week break between the 2 types of nTMS. Receives: Device: navigated rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI)
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Measured: Week 0
Tinnitus Handicap Inventory (THI)
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Measured: Week 3
Tinnitus Handicap Inventory (THI)
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Measured: Week 6
Tinnitus Handicap Inventory (THI)
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Measured: Week 7
Secondary outcomes (8)
Tinnitus Functional Index (TFI)
Tinnitus Functional Index (TFI) is a 25-item questionnaire with a 10-point Likert scale covering eight underlying dimensions: (a) intrusiveness of tinnitus; (b) sense of control; (c) cognitive interference; (d) sleep disturbance; (e) auditory difficulties; (f) interference with relaxation; (g) quality of life; and (h) emotional distress.
Measured: Week 0
Tinnitus Functional Index (TFI)
Tinnitus Functional Index (TFI) is a 25-item questionnaire with a 10-point Likert scale covering eight underlying dimensions: (a) intrusiveness of tinnitus; (b) sense of control; (c) cognitive interference; (d) sleep disturbance; (e) auditory difficulties; (f) interference with relaxation; (g) quality of life; and (h) emotional distress.
Measured: Week 3
Tinnitus Functional Index (TFI)
Tinnitus Functional Index (TFI) is a 25-item questionnaire with a 10-point Likert scale covering eight underlying dimensions: (a) intrusiveness of tinnitus; (b) sense of control; (c) cognitive interference; (d) sleep disturbance; (e) auditory difficulties; (f) interference with relaxation; (g) quality of life; and (h) emotional distress.
Measured: Week 6
Tinnitus Functional Index (TFI)
Tinnitus Functional Index (TFI) is a 25-item questionnaire with a 10-point Likert scale covering eight underlying dimensions: (a) intrusiveness of tinnitus; (b) sense of control; (c) cognitive interference; (d) sleep disturbance; (e) auditory difficulties; (f) interference with relaxation; (g) quality of life; and (h) emotional distress.
Measured: Week 7
Tinnitus-Visual Analogue Scale (T-VAS)
T-VAS is a clinical scale of the severity of tinnitus in loudness (sound), distress, and Quality of Life (QoL). The minimum value is 0 and the maximum value is 100. A higher score indicates a worse outcome, as it reflects greater perceived tinnitus loudness or severity. A score of 0 represents no tinnitus, while a score of 100 represents the worst imaginable tinnitus.
Measured: Week 0
Tinnitus-Visual Analogue Scale (T-VAS)
T-VAS is a clinical scale of the severity of tinnitus in loudness (sound), distress, and Quality of Life (QoL). The minimum value is 0 and the maximum value is 100. A higher score indicates a worse outcome, as it reflects greater perceived tinnitus loudness or severity. A score of 0 represents no tinnitus, while a score of 100 represents the worst imaginable tinnitus.
Measured: Week 3
Tinnitus-Visual Analogue Scale (T-VAS)
T-VAS is a clinical scale of the severity of tinnitus in loudness (sound), distress, and Quality of Life (QoL). The minimum value is 0 and the maximum value is 100. A higher score indicates a worse outcome, as it reflects greater perceived tinnitus loudness or severity. A score of 0 represents no tinnitus, while a score of 100 represents the worst imaginable tinnitus.
Measured: Week 6
Tinnitus-Visual Analogue Scale (T-VAS)
T-VAS is a clinical scale of the severity of tinnitus in loudness (sound), distress, and Quality of Life (QoL). The minimum value is 0 and the maximum value is 100. A higher score indicates a worse outcome, as it reflects greater perceived tinnitus loudness or severity. A score of 0 represents no tinnitus, while a score of 100 represents the worst imaginable tinnitus.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Nov 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Why it stopped: PI is on training overseas and not enough manpower. Will resume recruitment when PI is back.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- The study design is an open-label, prospective, sham-controlled crossover trial of neuronavigated TMS vs sham TMS.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Nicodemus Oey, MBBS, PhD, Principal investigator, NUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435298
- Sponsor's protocol ID
- 2024/4506
- Status last verified
- Dec 2025
- First submitted
- 20 Feb 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronavigated Transcranial Magnetic Stimulation As An Adjunctive Treatment For Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT07435298
- Acronym / sponsor ID
- 2024/4506
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI is on training overseas and not enough manpower. Will resume recruitment when PI is back.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Alexandra Hospital
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
This study is testing whether a special type of brain stimulation called neuronavigated TMS can help reduce tinnitus (ringing in the ears). 50 people with tinnitus will each receive 20 treatment sessions - 10 real treatments and 10 sham treatments in random order, with a 2-week break between them. Before starting, participants get an MRI brain scan to guide where the stimulation device is placed. Questionnaires of measuring tinnitus severity will be asked four times throughout the study to determine to check the effect of TMS on treating tinnitus.
Detailed description
This study aims to investigate the beneficial effects of neuronavigated TMS (nTMS) in alleviating tinnitus symptoms and to establish safety and tolerability of nTMS in patients with tinnitus.
50 eligible subjects will be recruited and be randomized to receive 10 sessions of daily verum nTMS followed by 10 sessions of daily sham nTMS (verum-sham), or sham nTMS followed by verum nTMS (sham-verum). There will be a 2-week break between the two types of nTMS.
MRI will be conducted before the 1st session of nTMS for the TMS navigation system.
Outcome measures include Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus-Visual Analogue Scale (T-VAS). All assessment will be evaluated 4 times- before the 1st nTMS session, after the 10th nTMS session, before the 11th nTMS and after the 20th nTMS session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design is an open-label, prospective, sham-controlled crossover trial of neuronavigated TMS vs sham TMS.
| Arm | Type | Receives |
|---|---|---|
| real-sham | Experimental | Device: navigated rTMSSubjects will receive 10 sessions of real nTMS, 5 times a week for 2 weeks, followed by 10 sessions of sham nTMS, 5 times a week for 2 weeks. There will be a 2-week break between the 2 types of nTMS. |
| sham-real | Experimental | Device: navigated rTMSSubjects will receive 10 sessions of sham nTMS, 5 times a week for 2 weeks, followed by 10 sessions of real nTMS, 5 times a week for 2 weeks. There will be a 2-week break between the 2 types of nTMS. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21-80 years old;
- Subjective tinnitus severity as per Tinnitus-Visual Analogue Scale of 1/10 and above (in any domain: sound, distress, Quality of Life)
Key exclusion criteria (9 listed)
- Pregnancy;
- Any metal implants inside the body that are contraindications of MRI scan;
- Cardiac pacemakers;
- Epilepsy with recurrent seizures;
- Cognitively impaired patients will be excluded;
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 |
|---|---|---|
| navigated rTMSEach session of rTMS (real or sham) consists of 1200 stimulations/day, conducted at once a day for five consecutive days (from Monday to Friday). For sham stimulation, the TMS coil will still centre on the same scalp position, but it was tilted to 90° so that scalp contact and discharging noise were similar, but the magnetic field did not reach cortical neurons at a biologically active level. The localization of the rTMS stimulation site (left Temporal Cortex) will be directed by a neuronavigation system imported with subject's MRI scan imaging to ensure the accuracy of rTMS stimulation area. | Device | real-sham, sham-real |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: Week 0
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
Time frame: Week 3
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
Time frame: Week 6
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
Time frame: Week 7
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
8 secondary outcomes
Tinnitus Functional Index (TFI)
Time frame: Week 0
Tinnitus Functional Index (TFI)
Time frame: Week 3
Tinnitus Functional Index (TFI)
Time frame: Week 6
Tinnitus Functional Index (TFI)
Time frame: Week 7
Tinnitus-Visual Analogue Scale (T-VAS)
Time frame: Week 0
Tinnitus-Visual Analogue Scale (T-VAS)
Time frame: Week 3
Tinnitus-Visual Analogue Scale (T-VAS)
Time frame: Week 6
Tinnitus-Visual Analogue Scale (T-VAS)
Time frame: Week 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Tinnitus
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Recruiting
Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Tinnitus, Tinnitus, Bilateral
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
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. This study is not recruiting at the moment.
Nicodemus Oey, MBBS, PhD principal investigator
NUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navigated rTMS in people with Tinnitus, run by National University Hospital, Singapore at 1 site in Singapore.
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 2 inclusion and 9 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: paused, as of the sponsor's last update on 23 Sep 2026. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI) (time frame: Week 0). The study lists 4 primary outcomes in all. 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 23 Sep 2026.