Navigated Repetitive TMS for Chronic Tinnitus

NCT07435298 | Recruiting

• 1 other identifier: 2024/4506
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Week 7

Secondary Outcomes (8)

• Tinnitus Functional Index (TFI)

  Week 0

• Tinnitus Functional Index (TFI)

  Week 3

• Tinnitus Functional Index (TFI)

  Week 6

• Tinnitus Functional Index (TFI)

  Week 7

• Tinnitus-Visual Analogue Scale (T-VAS)

  Week 0

Study Arms (2)

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.

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.

Device: navigated rTMS

Interventions

navigated rTMS DEVICE

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.

real-sham; sham-real

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Alexandra Hospital: collaborator

Study Sites (1)

Alexandra Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessor and participant will be blinded to the sequence of nTMS assigned to the subject.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is an open-label, prospective, sham-controlled crossover trial of neuronavigated TMS vs sham TMS.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)