Tinnitus
Conditions
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.
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
DEVICEnavigated 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.
Sponsors
National University Hospital, Singapore
Alexandra Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Assessor and participant will be blinded to the sequence of nTMS assigned to the subject.
Intervention model description
The study design is an open-label, prospective, sham-controlled crossover trial of neuronavigated TMS vs sham TMS.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Handicap Inventory (THI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Functional Index (TFI) | 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. |
| Tinnitus-Visual Analogue Scale (T-VAS) | Week 0 | 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. |
Countries
Singapore
Contacts
CONTACTNicodemus Oey, MBBS, PhD
PRINCIPAL_INVESTIGATORNicodemus Oey, MBBS, PhD
NUH
Outcome results
None listed