MRI-guided repetitive TMS to relieve chronic tinnitus
Neuronavigated Transcranial Magnetic Stimulation As An Adjunctive Treatment For Chronic Tinnitus
This trial will try MRI-guided repetitive transcranial magnetic stimulation to reduce ringing in the ears for adults with chronic tinnitus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07435298 on ClinicalTrials.gov |
What this trial studies
This randomized crossover trial will enroll 50 adults with chronic tinnitus who each receive 10 daily sessions of real neuronavigated rTMS and 10 daily sham sessions in random order, separated by a two-week break. A pre-treatment MRI is used to guide TMS targeting for each participant. Tinnitus severity will be measured using the Tinnitus Handicap Inventory, Tinnitus Functional Index, and a visual analogue scale at four timepoints around each treatment block. Safety and tolerability will be monitored throughout the study.
Who should consider this trial
Good fit: Adults aged 21–80 with subjective tinnitus (T-VAS ≥1/10) who can undergo MRI and do not have the listed medical or psychiatric exclusions.
Not a fit: Patients with MRI contraindications, pacemakers or other disallowed implants, epilepsy, major depression, uncontrolled medical conditions, or an expected life expectancy ≤1 year are excluded and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If effective, the approach could reduce tinnitus severity and improve daily functioning for some patients.
How similar studies have performed: Previous rTMS studies for tinnitus have shown mixed results with some small trials reporting modest benefit, so neuronavigated rTMS is promising but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore
- Alexandra Hospital — Singapore, Singapore (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.