Navigated Repetitive TMS for Chronic Tinnitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: navigated rTMS.
- Who it may be relevant to
- Registry conditions: Tinnitus. Basic parameters: 21 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neuronavigated Transcranial Magnetic Stimulation As An Adjunctive Treatment For Chronic Tinnitus
Overview
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.
Interventions
- 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 neuronaviga
Primary outcome measures
- Tinnitus Handicap Inventory (THI) [Time frame: Week 0]
- Tinnitus Handicap Inventory (THI) [Time frame: Week 3]
- Tinnitus Handicap Inventory (THI) [Time frame: Week 6]
- Tinnitus Handicap Inventory (THI) [Time frame: Week 7]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Singapore · 1 center
- Alexandra Hospital — Singapore
Identifiers
NCT: NCT07435298 · 2024/4506