Navigated Repetitive TMS for Chronic Tinnitus

February 20, 2026 updated by: National University Hospital, Singapore

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 21-80 years old;
  2. Subjective tinnitus severity as per Tinnitus-Visual Analogue Scale of 1/10 and above (in any domain: sound, distress, Quality of Life)

Exclusion Criteria:

  1. Pregnancy;
  2. Any metal implants inside the body that are contraindications of MRI scan;
  3. Cardiac pacemakers;
  4. Epilepsy with recurrent seizures;
  5. Cognitively impaired patients will be excluded;
  6. Claustrophobia;
  7. Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
  8. Major depression and a history of psychotic disorders;
  9. Terminal diagnosis with life expectancy <=1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: real-sham
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.
Device: navigated rTMS

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.
Experimental: sham-real
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.
Device: navigated rTMS

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0
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.
Week 3
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.
Week 6
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.
Week 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Functional Index (TFI)
Time Frame: Week 0
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.
Week 0
Tinnitus Functional Index (TFI)
Time Frame: Week 3
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.
Week 3
Tinnitus Functional Index (TFI)
Time Frame: Week 6
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.
Week 6
Tinnitus Functional Index (TFI)
Time Frame: Week 7
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.
Week 7
Tinnitus-Visual Analogue Scale (T-VAS)
Time Frame: Week 0
T-VAS is a clinical scale of the severity of tinnitus in loudness (sound), distress, and Quality of Life (QoL)
Week 0
Tinnitus-Visual Analogue Scale (T-VAS)
Time Frame: Week 3
T-VAS is a clinical scale of the severity of tinnitus in loudness (sound), distress, and Quality of Life (QoL)
Week 3
Tinnitus-Visual Analogue Scale (T-VAS)
Time Frame: Week 6
T-VAS is a clinical scale of the severity of tinnitus in loudness (sound), distress, and Quality of Life (QoL)
Week 6
Tinnitus-Visual Analogue Scale (T-VAS)
Time Frame: Week 7
T-VAS is a clinical scale of the severity of tinnitus in loudness (sound), distress, and Quality of Life (QoL)
Week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Alexandra Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/4506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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