About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Pregnancy;

Any metal implants inside the body that are contraindications of MRI scan;

Cardiac pacemakers;

Epilepsy with recurrent seizures;

Trial design

Design model

Crossover

Treatments tested in this trial

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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: real-shamExperimental treatment 1 intervention

Group B: sham-realExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

Week 0

2

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.

Time frame

Week 3

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.

Time frame

Week 6

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.

Time frame

Week 7

Secondary outcomes

1

Tinnitus Functional Index (TFI)

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.

Time frame

Week 0

2

Tinnitus Functional Index (TFI)

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.

Time frame

Week 3

3

Tinnitus Functional Index (TFI)

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.

Time frame

Week 6

4

Tinnitus Functional Index (TFI)

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.

Time frame

Week 7

Navigated Repetitive TMS for Chronic Tinnitus

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts