Tinnitus
Conditions
Keywords
tinnitus, repetitive transcranial magnetic stimulation
Brief summary
The aim of this study is to compare the efficacy of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) and 1Hz rTMS for the treatment of chronic subjective tinnitus. In this single-blind randomized controlled study, patients will be randomly assigned 1:1 to receive two different types of rTMS stimulation.
Detailed description
Tinnitus is a common disorder with a prevalence of 10-25% among adults, which seriously affects the quality of life of patients. Many studies have reported significant efficacy of repetitive transcranial magnetic stimulation (rTMS) for tinnitus, but its optimal stimulation parameters are not clear. Therefore, there is necessary to assess the clinical efficacy and mechanism of different types of rTMS for the treatment of chronic subjective tinnitus through rigorously designed clinical studies. The study will assess the severity of tinnitus and the mood and sleep status of the patients through several scales and tinnitus psychoacoustic assessment before treatment, after treatment and at follow-up. The primary research hypothesis is that frequency-specific patterned rTMS will be superior to 1Hz rTMS in reducing tinnitus-related distress.
Interventions
DEVICEfrequency-specific rTMS
Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals
DEVICE1 Hz rTMS
Low-frequency rTMS will be performed at a frequency of 1Hz
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged between 18 and 80 years old. 2. Experiencing persistant subjective tinnitus for at least 3 months. 3. A score of 38 or more on THI. 4. 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear. 5. Voluntarily participate in the study and sign the informed consent form. 6. Have normal mental status and cognitive function, and be able to cooperate with the research process.
Exclusion criteria
1. Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus. 2. History of epilepsy or stroke. 3. Diagnosis of acoustic neuroma. 4. Severe sensorineural hearing loss. 5. Surgically or traumatically implanted ferromagnetic foreign bodies, including but not limited to pacemakers, neurostimulators, prosthetic metal heart valves, aneurysm clips (non-titanium alloy), intraocular metal foreign bodies, cochlear implants, metal prostheses, metal joints, fixed steel plates or steel pins. 6. Patients with active metal foreign bodies (metal implants, dentures, contraceptive rings), insulin pumps, etc., who have been evaluated in detail and are at risk for rTMS treatment. 7. Patients taking vestibular sedatives, antipsychotics, anxiolytics, antiepileptics, and ototoxic drugs. 8. Patients with a recent history of alcohol or drug abuse 9. Bell's palsy 10. Acute ear infection within the last 1 month 11. Inability to cooperate or complete the study process 12. Participation in another clinical trial within the last month. 13. Have any condition that may affect compliance or safety 14. Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Handicap Inventory (THI) | 5 days from baseline | The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a yes (4 points), sometimes (2 points), and no (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Masking Level (MML) | 5 days from baseline | The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus. |
| Tinnitus Loudness Matching (LM) | 5 days from baseline | Used to measure tinnitus loudness. The level of intensity of an external sound that the patient perceives as equivalent to their tinnitus is used as the LM measurement. |
| Visual Analogue Scale (VAS) | 5 days from baseline | Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder). |
| Self-rating Anxiety Scale (SAS) | 5 days from baseline | The SAS is a concise, validated tool for assessing anxiety levels in research and clinical settings. It comprises 20 items rated on a 4-point scale, summing to a total score indicating anxiety severity. |
| Athens Insomnia Scale (AIS) | 5 days from baseline | The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24). |
| Duration and intensity of residual inhibition (RI) for tinnitus | 5 days from baseline | Used to measure the duration and intensity of RI for tinnitus. |
Countries
China
Contacts
Primary ContactShan Sun, PhD
Backup ContactDongmei Tang, PhD
Outcome results
None listed